APO-go

Glavne informacije

  • Zaščiteno ime:
  • APO-go 5 mg/ml raztopina za infundiranje v napolnjeni injekcijski brizgi
  • Farmacevtska oblika:
  • Raztopina za infundiranje
  • Sestava:
  • apomorfin 2,27 mg / 1 ml
  • Pot uporabe:
  • Subkutana uporaba
  • Enote v paketu:
  • škatla s 5 napolnjenimi injekcijskimi brizgami z 10 ml raztopine
  • Tip zastaranja:
  • Rp/Spec - Predpisovanje in izdaja zdravila je le na recept zdravnika specialista ustreznega področja medicine ali od njega poobl
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

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Lokalizacija

  • Na voljo v:
  • APO-go 5 mg/ml raztopina za infundiranje v napolnjeni injekcijski brizgi
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • apomorfin

Drugi podatki

Stanje

  • Source:
  • JAZMP - Javna agencija RS za zdravila in medicinske pripomočke - Slovenia Medicines Agency
  • Status dovoljenje:
  • Zdravilo z dovoljenjem za promet
  • Številka dovoljenja:
  • 11011-55/2015-5
  • Datum dovoljenje:
  • 30-05-2017
  • EAN koda:
  • 3837000132557
  • Zadnja posodobitev:
  • 25-05-2018

Podatki za bolnike

Navodilo za uporabo

APO-go 5 mg/ml raztopina za infundiranje v napolnjeni injekcijski brizgi*

apomorfinijev klorid

*V besedilu se uporablja skrajšano ime APO-go

50 mg/ 10 ml

Zdravilo se uporablja pri odraslih.

Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne

podatke!

Navodilo shranite. Morda ga boste želeli ponovno prebrati.

Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.

Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim. Njim bi lahko celo škodovalo,

čeprav imajo znake bolezni, podobne vašim.

Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko

sestro. Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu.

Glejte poglavje 4.

Kaj vsebuje navodilo

1. Kaj je zdravilo APO-go in za kaj ga uporabljamo

2. Kaj morate vedeti, preden boste uporabili zdravilo APO-go

3. Kako uporabljati zdravilo APO-go

4. Možni neželeni učinki

5. Shranjevanje zdravila APO-go

6. Vsebina pakiranja in dodatne informacije

1.

Kaj je zdravilo APO-go in za kaj ga uporabljamo

Zdravilo APO-go vsebuje apomorfinijev klorid. Apomorfinijev klorid spada v skupino zdravil,

imenovanih agonisti dopamina, ki se uporabljajo za zdravljenje Parkinsonove bolezni. Apomorfin

pomaga skrajšati čas močno oviranega stanja oziroma “izklopa” pri ljudeh, ki so pred tem za zdravljenje

Parkinsonove bolezni jemali levodopo in/ali druge agoniste dopamina. Vaš zdravnik ali medicinska sestra

vam bosta pomagala prepoznati znake, pri katerih boste morali uporabiti zdravilo.

Kljub temu, da se učinkovina imenuje apomorfin, ne vsebuje morfina.

2.

Kaj morate vedeti, preden boste uporabili zdravilo APO-go

Preden začnete uporabljati zdravilo APO-go, bo vaš zdravnik opravil pregled z elektrokardiogramom

(EKG) in vas prosil za seznam vseh drugih zdravil, ki jih jemljete. Ta pregled EKG se bo ponovil v prvih

dneh zdravljenja in kadar koli, ko bo to po zdravnikovem mnenju potrebno. Vprašal vas bo tudi o drugih

boleznih, ki jih morda imate, zlasti povezanih s srcem. Nekatera vprašanja in preiskave se bodo morda

ponovili ob vsakem obisku zdravnika. Če se pri vas pojavijo simptomi, ki so morda povezani s srcem,

npr. palpitacije, omedlevica ali skorajšnja omedlevica, morate to takoj sporočiti svojemu zdravniku.

Zdravnika morate obvestiti tudi, če imate drisko ali začnete uporabljati novo zdravilo.

Ne uporabljajte zdravila APO-go, če:

ste mlajši od 18 let;

imate težave pri dihanju ali astmo;

imate demenco ali Alzheimerjevo bolezen;

ste zmedeni oziroma imate halucinacije ali druge podobne težave;

imate težave z jetri;

imate hudo diskinezijo (nehoteni gibi) ali hudo distonijo (nezmožnost gibanja) zaradi zdravljenja z

levodopo;

ste alergični na apomorfin ali katero koli sestavino tega zdravila (navedeno v poglavju 6);

imate vi ali kdo v vaši družini na elektrokardiogramu (EKG) nepravilnost, imenovano "sindrom

podaljšanega intervala QT".

Opozorila in previdnostni ukrepi

Pred začetkom uporabe zdravila APO-go se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro,

če:

imate težave z ledvicami;

imate težave s pljuči;

imate težave s srcem;

imate nizek krvni tlak ali v stoječem položaju občutite omedlevico in vrtoglavico;

jemljete kakršna koli zdravila za zdravljenje visokega krvnega tlaka;

občutite slabost ali trpite zaradi slabosti;

imate kakršne koli duševne bolezni ob začetku uporabe zdravila APO-go;

ste starejši ali slabotni.

Obvestite svojega zdravnika, če vi ali vaša družina/skrbnik opazite, da se pri vas razvija potreba ali

hrepenenje, da se obnašate na način, ki ni običajen za vas in se ne morete upreti impulzu, želji ali

skušnjavi, da bi izvedli določena dejanja, ki bi lahko škodili vam ali drugim. To vedenje se imenuje

motnja kontrole impulzov in lahko vključuje zasvojenost z igranjem na srečo, prekomerno hranjenje ali

zapravljanje, nenormalno visok libido ali povečanje seksualnih misli ali občutkov. Vaš zdravnik bo morda

moral prilagoditi ali ukiniti odmerek.

Pri nekaterih bolnikih se razvijejo zasvojenosti podobni simptomi, ki vodijo v hrepenenje po velikih

odmerkih zdravila APO-go in drugih zdravil, ki se uporabljajo za zdravljenje Parkinsonove bolezni.

Če se karkoli od zgoraj naštetega nanaša na vas, o tem obvestite svojega zdravnika ali medicinsko sestro.

Otroci in mladostniki

Zdravila APO-go se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.

Druga zdravila in zdravilo APO-go

Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli

uporabljati katero koli drugo zdravilo.

Posvetujte se z zdravnikom ali farmacevtom, preden uporabite to zdravilo, če:

jemljete zdravila, za katera je znano, da vplivajo na način bitja srca. To vključuje zdravila, ki se

uporabljajo pri motnjah srčnega ritma (kot sta kinidin in amiodaron), pri depresiji (vključno s

tricikličnimi antidepresivi, kot sta amitriptilin in imipramin) in pri bakterijskih okužbah (makrolidni

antibiotiki, kot so eritromicin, azitromicin in klaritromicin) ter domperidon.

Če uporabljate to zdravilo v kombinaciji z drugimi zdravili, se lahko učinek teh zdravil spremeni. To še

zlasti velja za:

zdravila, kot je klozapin, za zdravljenje nekaterih duševnih bolezni;

zdravila za zniževanje krvnega tlaka;

druga zdravila za zdravljenje Parkinsonove bolezni.

Vaš zdravnik vam bo povedal, če je pri vas potrebno prilagoditi odmerek apomorfina ali katerega koli

drugega zdravila, ki ga jemljete.

Če jemljete levodopo (drugo zdravilo za zdravljenje Parkinsonove bolezni) in apomorfin, bo zdravnik

moral pri vas pogosteje izvajati preiskave krvi.

Zdravilo APO-go skupaj s hrano in pijačo

Hrana in pijača ne vplivata na delovanje zdravila APO-go.

Nosečnost in dojenje

Zdravila APO-go ne smete uporabljati med nosečnostjo, razen če je nujno potrebno. Če ste noseči,

menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom,

preden uporabite zdravilo APO-go.

Ni znano, ali zdravilo APO-go prehaja v materino mleko. Povejte svojemu zdravniku, če dojite ali

nameravate začeti dojiti. Vaš zdravnik vam bo svetoval pri odločitvi, ali nadaljevati ali prekiniti dojenje

oziroma ali nadaljevati ali prekiniti uporabo tega zdravila.

Posvetujte se z zdravnikom ali farmacevtom, preden vzamete katero koli zdravilo.

Vpliv na sposobnost upravljanja vozil in strojev

Če vas zdravilo APO-go uspava, ne smete voziti. Če vas zdravilo APO-go uspava, ne smete uporabljati

orodij, niti strojev.

Zdravilo APO-go vsebuje natrijev metabisulfit

Zdravilo APO-go vsebuje natrijev metabisulfit, ki redko lahko povzroči hude alergijske reakcije s

simptomi, kot so kožni izpuščaji ali srbeča koža, težave pri dihanju, oteklost vek, obraza ali ustnic ter

otekanje ali pordelost jezika. Če se pri vas pojavijo ti neželeni učinki, nemudoma poiščite najbližjo enoto

nujne medicinske pomoči.

Zdravilo APO-go vsebuje manj kot 1 mmol (23 mg) natrija v 10 ml, kar v bistvu pomeni brez natrija.

3.

Kako uporabljati zdravilo APO-go

Pred uporabo zdravila APO-go se bo zdravnik prepričal, ali dobro prenašate to zdravilo in antiemetično

zdravilo, ki ga morate uporabljati sočasno.

Infuzija se daje podkožno (to je v področje pod kožo).

Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika ali farmacevta. Če ste negotovi, se

posvetujte z zdravnikom ali farmacevtom.

Ne uporabljajte zdravila APO-go:

Če se je barva raztopine spremenila v zeleno.

Zdravilo APO-go je primerno za neprekinjeno infuzijo s potisnim mehanizmom v brizgi. Ni pa

primerno za občasno injiciranje. O tem, katero majhno črpalko in/ali potisni mehanizem v brizgi in

katero nastavitev odmerka je treba izbrati, bo odločil zdravnik.

Koliko zdravila uporabiti

Tako količina zdravila APO-go, ki jo morate prejeti, kot skupni čas prejemanja zdravila na dan sta

odvisna od vaših osebnih potreb. Vaš zdravnik se bo o tem pogovoril z vami in vam bo povedal, kakšno

količino zdravila morate prejeti. Odmerek, ki bo za vas najprimernejši, bo določen med vašim obiskom

specialistične klinike. Povprečni urni odmerek infuzije znaša med 1 mg in 4 mg apomorfinijevega klorida.

Običajno se neprekinjena infuzija daje, ko ste budni, z dajanjem pa se preneha, preden greste spat.

Odmerek apomorfinijevega klorida, ki ga prejmete dnevno, ne sme presegati 100 mg. Vaš zdravnik ali

medicinska sestra bosta odločila, kakšen odmerek je najboljši za vas.

Mesto infundiranja je treba spremeniti vsakih 12 ur.

To zdravilo se ne sme dati v veno.

Zdravila APO-go ni treba razredčiti pred uporabo. Poleg tega se ga ne sme mešati z drugimi zdravili.

Če ste uporabili večji odmerek zdravila APO-go, kot bi smeli

Takoj se obrnite na svojega zdravnika ali najbližjo enoto nujne medicinske pomoči.

Pomembno je, da prejmete ustrezen odmerek zdravila APO-go, ne pa več, kot vam je priporočil vaš

zdravnik. Pri večjih odmerkih lahko pride do upočasnjenega bitja srca, hude slabosti, prekomerne

zaspanosti in/ali težav pri dihanju. Zaradi nizkega krvnega tlaka lahko občutite tudi omedlevico ali

vrtoglavico, še zlasti ob vstajanju. V primeru nizkega krvnega tlaka bo k boljšemu počutju

pripomoglo to, da se uležete in dvignete noge.

Če ste pozabili uporabiti zdravilo APO-go

Zdravilo uporabite naslednjič, ko ga potrebujete. Ne uporabite dvojnega odmerka, da bi nadomestili

izpuščeni odmerek.

Če ste prenehali uporabljati zdravilo APO-go

Preden prenehate z zdravljenjem, se posvetujte s svojim zdravnikom glede tega, ali je to primerno ali ne.

Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, farmacevtom ali medicinsko

sestro.

4.

Možni neželeni učinki

Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih. Če

mislite, da se zaradi zdravila počutite slabo, ali če se pri vas pojavi kateri koli izmed spodaj navedenih

neželenih učinkov, o tem obvestite svojega zdravnika:

Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov

bule pod kožo na mestu injiciranja, ki so boleče, neprijetne, lahko pa tudi rdeče in srbeče; da bi

preprečili nastajanje bul, je priporočljivo pri vsakem vbodu z iglo zamenjati mesto injiciranja;

halucinacije (videnje, občutenje ali slišanje stvari, ki jih ni).

Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov

slabost ali občutek slabosti, še zlasti na začetku uporabe zdravila APO-go; da bi preprečili slabost ali

občutek slabosti, morate najmanj 2 dni pred začetkom uporabe zdravila APO-go začeti jemati

domperidon; če jemljete domperidon in je pri vas še vedno prisoten občutek slabosti, ali če ne

jemljete domperidona in občutite slabost, to čim prej povejte svojemu zdravniku ali medicinski sestri;

občutek utrujenosti ali prekomerne zaspanosti;

zmedenost ali halucinacije;

zehanje;

občutek omotice ali vrtoglavice ob vstajanju.

Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov

izraziti nehoteni gibi ali okrepitev tresenja med 'vklopom';

hemolitična anemija, nenormalna razgradnja rdečih krvnih celic v krvnih žilah ali drugod po telesu; to

je občasen neželen učinek, do katerega lahko pride pri bolnikih, ki jemljejo tudi levodopo;

nenaden nepremagljiv spanec;

izpuščaji;

težave pri dihanju;

razjede na mestu injiciranja;

zmanjšano število rdečih krvnih celic, zaradi česar lahko koža postane bledo rumena, pojavi pa se

lahko tudi oslabelost ali zasoplost;

zmanjšano število trombocitov, zaradi česar se poveča nevarnost krvavitve ali nastanka modric.

Redki: pojavijo se lahko pri največ 1 od 1.000 bolnikov

alergijska reakcija, na primer:

težave pri dihanju ali stiskanje v prsnem košu;

oteklost vek, obraza ali ustnic;

otekanje ali pordelost jezika;

eozinofilija, nenormalno veliko število belih krvnih celic v krvi ali v telesnih tkivih.

Neznana pogostnost: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti

otekanje nog, stopal ali prstov;

nezmožnost, da bi se uprli impulzu, želji ali skušnjavi za izvedbo določenega dejanja, ki bi lahko

škodilo vam ali drugim, ki lahko vključuje:

močan impulz za prekomerno igranje na srečo, kljub resnim posledicam za vas ali za

družino;

spremenjeno ali povečano zanimanje za spolnost in skrb vzbujajoče obnašanje za vas ali

za druge, na primer povečan libido;

nekontrolirano prekomerno nakupovanje ali zapravljanje;

prekomerno hranjenje (če pojeste velike količine hrane v kratkem časovnem obdobju) ali

kompulzivno hranjenje (če pojeste več hrane, kot je normalno in več, kot je potrebno za

potešitev lakote);

omedlevica;

agresivnost, huda tesnoba z motoričnim nemirom;

glavobol.

Povejte svojemu zdravniku, če občutite katerega koli od teh vedenjskih vzorcev; pogovorili se boste

o načinih odpravljanja ali zmanjševanja teh simptomov.

Poročanje o neželenih učinkih

Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali

medicinsko sestro. Posvetujte se tudi, če opazite neželene učinke, ki niso navedeni v tem navodilu. O

neželenih učinkih lahko poročate tudi neposredno na:

Javna agencija Republike Slovenije za zdravila in medicinske pripomočke

Sektor za farmakovigilanco

Nacionalni center za farmakovigilanco

Slovenčeva ulica 22

SI-1000 Ljubljana

Tel: +386 (0)8 2000 500

Faks: +386 (0)8 2000 510

e-pošta: h-farmakovigilanca@jazmp.si

spletna stran: www.jazmp.si

S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega

zdravila.

5.

Shranjevanje zdravila APO-go

Zdravilo shranjujte nedosegljivo otrokom!

Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.

Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.

Napolnjene injekcijske brizge shranjujte v zunanji škatli za zagotovitev zaščite pred svetlobo.

Shranjujte pri temperaturi do 25 °C.

Zdravilo APO-go uporabite takoj po odprtju, vso neporabljeno raztopino pa zavrzite.

Samo za enkratno uporabo.

Ne uporabljajte zdravila APO-go, če se je barva raztopine spremenila v zeleno. Uporabite lahko le bistro

in brezbarvno raztopino, v kateri ne opazite delcev.

Vsebino iztisnite takoj po odprtju. Pazite na to, da raztopine ne brizgate po sebi ali po preprogi, saj lahko

raztopina pusti zelene madeže. Po uporabi zavrzite stekleno injekcijsko brizgo v posodo za odlaganje

ostrih predmetov, prav tako pa tudi vse uporabljene plastične brizge in adapter.

Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke. O načinu odstranjevanja

zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom. Taki ukrepi pomagajo varovati okolje.

6.

Vsebina pakiranja in dodatne informacije

Kaj vsebuje zdravilo APO-go

Zdravilna učinkovina je apomorfinijev klorid. 1 ml raztopine vsebuje 5 mg apomorfinijevega klorida.

Ena 10-mililitrska napolnjena injekcijska brizga vsebuje 50 mg apomorfinijevega klorida.

Druge sestavine zdravila so:

natrijev metabisulfit (E223),

koncentrirana klorovodikova kislina,

voda za injekcije.

Za natrijev metabisulfit glejte poglavje 2: Zdravilo APO-go vsebuje natrijev metabisulfit.

Izgled zdravila APO-go in vsebina pakiranja

Zdravilo APO-go je raztopina za infundiranje v napolnjeni injekcijski brizgi. Raztopina je bistra in

brezbarvna.

Vsebina pakiranja

Zdravilo APO-go je na voljo v napolnjeni injekcijski brizgi iz prozornega stekla.

Posamezno pakiranje ima 5 brizg, ki vsebujejo 10 ml raztopine, v zunanji kartonasti škatli.

Ponekod so na voljo pakiranja v paketih s 25 (5 x 5) in 50 (10 x 5) kosi.

Na trgu morda ni vseh navedenih pakiranj.

Način in režim izdaje zdravila APO-go

Rp/Spec - Predpisovanje in izdaja zdravila je le na recept zdravnika specialista ustreznega področja

medicine ali od njega pooblaščenega zdravnika.

Imetnik dovoljenja za promet z zdravilom in izdelovalec

Imetnik dovoljenja za promet z zdravilom

Britannia Pharmaceuticals Ltd.

200 Longwater Avenue

Green Park

Reading, Berkshire

RG2 6GP

Združeno kraljestvo

Izdelovalci

Britannia Pharmaceuticals Ltd.

200 Longwater Avenue

Green Park

Reading, Berkshire

RG2 6GP

Združeno kraljestvo

Catalent Belgium S.A.

Font Saint Landry 10

B-1120 Brussels (Neder Over Heembeek)

Belgija

Rovi Contract Manufacturing, S.L.

Julián Camarillo, 35

Madrid 28037

Španija

STADA Arzneimittel AG

Stadastraße 2 – 18

61118 Bad Vilbel

Nemčija

To zdravilo je v državah članicah EGP pridobilo dovoljenje za promet pod naslednjimi imeni:

Avstrija, Nemčija:

APO-go 5 mg/ml Infusionslösung in einer Fertigspritze

Bolgarija:

APO-go PFS 5 mg/ml Разтвор за инфузия в предварително напълнена

спринцовка

Ciper:

APO-go® PFS 5 mg/ml Διάλυμα για Έγχυση σε Προγεμισμένη Σύριγγα

Danska:

APO-go Pumpfill 5 mg/ml infusionsvæske, opløsning i fyldt injektionssprøjte

Luksemburg:

APOGO 5 mg/ml Solution pour Perfusion en Seringue Préremplie

Grčija:

APO-go PFS 5 mg/ml Διάλυμα για Έγχυση σε Προγεμισμένη Σύριγγα

Irska, Združeno kraljestvo, Malta:

APO-go PFS 5 mg/ml Solution for Infusion in Pre-filled Syringe

Nizozemska:

APO-go 5 mg/ml oplossing voor infusie in een voorgevulde spuit

Norveška:

Britaject 5 mg/ml infusjonsvæske, oppløsning i ferdigfylt sprøyte

Portugalska:

Apo-go 5 mg/ml Solução para perfusão em seringa pré-cheia

Romunija:

APO-go 5 mg/ml soluţie perfuzabilă în seringă preumplută unidoză

Slovenija:

APO-go 5 mg/ml raztopina za infundiranje v napolnjeni injekcijski brizgi

Španija:

APO-go PFS 5 mg/ml Solución para Perfusión en Jeringa Precargada

Švedska:

APO-go Pumpfill 5 mg/ml infusionsvätska, lösning i förfylld spruta

Navodilo je bilo nazadnje revidirano

dne 7. 12. 2017.

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

6-10-2018

Ladyfingers Gourmet to Go Voluntarily Recalls Signature Shaved Country Ham Rolls Due to Possible Health Risk

Ladyfingers Gourmet to Go Voluntarily Recalls Signature Shaved Country Ham Rolls Due to Possible Health Risk

Ladyfingers Caterers is voluntarily recalling its Signature Shaved Country Ham Rolls as a result of the Johnston County Hams recall. The rolls were made with ham produced by Johnston County Hams, which recently initiated a recall of its ham products due to possible contamination with Listeria monocytogenes. Listeria monocytogenes can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer onl...

FDA - U.S. Food and Drug Administration

19-11-2018

The #FDA wants to promote the development of #digitaltech that can also help guide the safe and effective use of prescription drugs, to help patients improve their health  https://go.usa.gov/xPAak pic.twitter.com/nRPaMkKini

The #FDA wants to promote the development of #digitaltech that can also help guide the safe and effective use of prescription drugs, to help patients improve their health https://go.usa.gov/xPAak pic.twitter.com/nRPaMkKini

The #FDA wants to promote the development of #digitaltech that can also help guide the safe and effective use of prescription drugs, to help patients improve their health https://go.usa.gov/xPAak  pic.twitter.com/nRPaMkKini

FDA - U.S. Food and Drug Administration

14-11-2018

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or   manage pain:  https://go.usa.gov/x

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/x

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/xPfuw  #FDA #MedicalDevice pic.twitter.com/kgDSx2PQzn

FDA - U.S. Food and Drug Administration

13-11-2018

#DYK November is #DiabetesAwarenessMonth. As the number of people diagnosed with diabetes continues to grow, @US_FDA  encourages patients and caregivers to beware of illegally markets  diabetes treatments. Check out our Consumer Update on this issue  http

#DYK November is #DiabetesAwarenessMonth. As the number of people diagnosed with diabetes continues to grow, @US_FDA encourages patients and caregivers to beware of illegally markets diabetes treatments. Check out our Consumer Update on this issue http

#DYK November is #DiabetesAwarenessMonth. As the number of people diagnosed with diabetes continues to grow, @US_FDA encourages patients and caregivers to beware of illegally markets diabetes treatments. Check out our Consumer Update on this issue https://go.usa.gov/xPfDx  pic.twitter.com/OGwOusdP1w

FDA - U.S. Food and Drug Administration

13-11-2018

Check out the #PEAC2018 agenda, webcast information, and meeting materials for Thursday’s Patient Engagement Advisory Committee meeting on  http://FDA.gov : https://go.usa.gov/xPf9n  #DigitalHealthpic.twitter.com/1DCieYB33v

Check out the #PEAC2018 agenda, webcast information, and meeting materials for Thursday’s Patient Engagement Advisory Committee meeting on http://FDA.gov : https://go.usa.gov/xPf9n  #DigitalHealthpic.twitter.com/1DCieYB33v

Check out the #PEAC2018 agenda, webcast information, and meeting materials for Thursday’s Patient Engagement Advisory Committee meeting on http://FDA.gov : https://go.usa.gov/xPf9n  #DigitalHealth pic.twitter.com/1DCieYB33v

FDA - U.S. Food and Drug Administration

9-11-2018

Recent Ebola outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of today’s EUA is an important step in addressing these outbreaks.  http://go.usa.gov/xPvs4 pic.twitter.com/o2I1dYUQCx

Recent Ebola outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of today’s EUA is an important step in addressing these outbreaks. http://go.usa.gov/xPvs4 pic.twitter.com/o2I1dYUQCx

Recent Ebola outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of today’s EUA is an important step in addressing these outbreaks. http://go.usa.gov/xPvs4  pic.twitter.com/o2I1dYUQCx

FDA - U.S. Food and Drug Administration

8-11-2018

Learn more about the #PEAC2018 meeting:  https://go.usa.gov/xPvTx   #DigitalHealth

Learn more about the #PEAC2018 meeting: https://go.usa.gov/xPvTx  #DigitalHealth

Learn more about the #PEAC2018 meeting: https://go.usa.gov/xPvTx  #DigitalHealth

FDA - U.S. Food and Drug Administration

6-11-2018

November is #DiabetesAwarenessMonth  #DYK using a glucose meter to check and monitor blood sugar is a daily part of life for millions of Americans with diabetes? Check out the @US_FDA's tips on how to safely use glucose meters and test strips for diabetes

November is #DiabetesAwarenessMonth #DYK using a glucose meter to check and monitor blood sugar is a daily part of life for millions of Americans with diabetes? Check out the @US_FDA's tips on how to safely use glucose meters and test strips for diabetes

November is #DiabetesAwarenessMonth #DYK using a glucose meter to check and monitor blood sugar is a daily part of life for millions of Americans with diabetes? Check out the @US_FDA's tips on how to safely use glucose meters and test strips for diabetes: https://go.usa.gov/xPdK4 

FDA - U.S. Food and Drug Administration

2-11-2018

.@US_FDA  issues a class I recall: Roche Diagnostics recalls CoaguChek  XS PT Test  Strips due to inaccurate INR test results. Find out more:  https://go.usa.gov/xPVER  #FDA #MedicalDevicepic.twitter.com/EYmVZHrUZc

.@US_FDA issues a class I recall: Roche Diagnostics recalls CoaguChek XS PT Test Strips due to inaccurate INR test results. Find out more: https://go.usa.gov/xPVER  #FDA #MedicalDevicepic.twitter.com/EYmVZHrUZc

. @US_FDA issues a class I recall: Roche Diagnostics recalls CoaguChek XS PT Test Strips due to inaccurate INR test results. Find out more: https://go.usa.gov/xPVER  #FDA #MedicalDevice pic.twitter.com/EYmVZHrUZc

FDA - U.S. Food and Drug Administration

2-11-2018

Check out @US_FDA's information on Direct-to-Consumer Tests:  https://go.usa.gov/xPVPu  #MedicalDevice #FDA

Check out @US_FDA's information on Direct-to-Consumer Tests: https://go.usa.gov/xPVPu  #MedicalDevice #FDA

Check out @US_FDA's information on Direct-to-Consumer Tests: https://go.usa.gov/xPVPu  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

2-11-2018

#DYK the @US_FDA recently authorized the first direct-to-consumer test   for detecting genetic variants that may be associated with medication   metabolism? Learn more about the authorization:  https://go.usa.gov/xPVUt  #MedicalDevice #FDA

#DYK the @US_FDA recently authorized the first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism? Learn more about the authorization: https://go.usa.gov/xPVUt  #MedicalDevice #FDA

#DYK the @US_FDA recently authorized the first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism? Learn more about the authorization: https://go.usa.gov/xPVUt  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

1-11-2018

The @US_FDA issues a letter to health care providers regarding possible battery failure in Getinge's Maquet/Datascope intra-aortic balloon pumps. Read the letter here:  https://go.usa.gov/xPyHT  #MedicalDevice

The @US_FDA issues a letter to health care providers regarding possible battery failure in Getinge's Maquet/Datascope intra-aortic balloon pumps. Read the letter here: https://go.usa.gov/xPyHT  #MedicalDevice

The @US_FDA issues a letter to health care providers regarding possible battery failure in Getinge's Maquet/Datascope intra-aortic balloon pumps. Read the letter here: https://go.usa.gov/xPyHT  #MedicalDevice

FDA - U.S. Food and Drug Administration

1-11-2018

The @US_FDA warns patients & health care providers should not change drug treatment based on results from certain genetic tests w/ unapproved claims to predict a patient’s response to specific medications. Read the Safety Communication here:  https://go.u

The @US_FDA warns patients & health care providers should not change drug treatment based on results from certain genetic tests w/ unapproved claims to predict a patient’s response to specific medications. Read the Safety Communication here: https://go.u

The @US_FDA warns patients & health care providers should not change drug treatment based on results from certain genetic tests w/ unapproved claims to predict a patient’s response to specific medications. Read the Safety Communication here: https://go.usa.gov/xPysF  #MedicalDevice

FDA - U.S. Food and Drug Administration

30-10-2018

#DYK: Mammograms are still the best tool for breast cancer screening.  Check out @US_FDA’s information on the importance of choosing a certified mammography facility:  https://go.usa.gov/xPPpT  #MedicalDevice #BreastCancerAwarenessMonthpic.twitter.com/YaG

#DYK: Mammograms are still the best tool for breast cancer screening. Check out @US_FDA’s information on the importance of choosing a certified mammography facility: https://go.usa.gov/xPPpT  #MedicalDevice #BreastCancerAwarenessMonthpic.twitter.com/YaG

#DYK: Mammograms are still the best tool for breast cancer screening. Check out @US_FDA’s information on the importance of choosing a certified mammography facility: https://go.usa.gov/xPPpT  #MedicalDevice #BreastCancerAwarenessMonth pic.twitter.com/YaGqeGgrTH

FDA - U.S. Food and Drug Administration

26-10-2018

Men can also be diagnosed with breast cancer. Check out the @US_FDA’s information regarding breast cancer in men, available treatments and counseling options:  https://go.usa.gov/xPPpx  ) #MedicalDevice #BreastCancerAwarenessMonthpic.twitter.com/aZBjgCGsB

Men can also be diagnosed with breast cancer. Check out the @US_FDA’s information regarding breast cancer in men, available treatments and counseling options: https://go.usa.gov/xPPpx  ) #MedicalDevice #BreastCancerAwarenessMonthpic.twitter.com/aZBjgCGsB

Men can also be diagnosed with breast cancer. Check out the @US_FDA’s information regarding breast cancer in men, available treatments and counseling options: https://go.usa.gov/xPPpx  ) #MedicalDevice #BreastCancerAwarenessMonth pic.twitter.com/aZBjgCGsB1

FDA - U.S. Food and Drug Administration

24-10-2018

Stay informed of the most effective breast cancer screening options by checking out our consumer update warning against the use of thermography as mammogram substitute:  https://go.usa.gov/xPUA7  #FDA #MedicalDevice #BreastCancerAwarenessMonth

Stay informed of the most effective breast cancer screening options by checking out our consumer update warning against the use of thermography as mammogram substitute: https://go.usa.gov/xPUA7  #FDA #MedicalDevice #BreastCancerAwarenessMonth

Stay informed of the most effective breast cancer screening options by checking out our consumer update warning against the use of thermography as mammogram substitute: https://go.usa.gov/xPUA7  #FDA #MedicalDevice #BreastCancerAwarenessMonth

FDA - U.S. Food and Drug Administration

21-10-2018

It’s concerning that many women who qualify for a mammogram don’t go for regular screening, in part due to common myths like mammograms “are painful” or “cause cancer.”  During this Breast Cancer Awareness month, I urge women to check the facts  https://g

It’s concerning that many women who qualify for a mammogram don’t go for regular screening, in part due to common myths like mammograms “are painful” or “cause cancer.” During this Breast Cancer Awareness month, I urge women to check the facts https://g

It’s concerning that many women who qualify for a mammogram don’t go for regular screening, in part due to common myths like mammograms “are painful” or “cause cancer.” During this Breast Cancer Awareness month, I urge women to check the facts https://go.usa.gov/xPnyD . pic.twitter.com/DGz5Xvquky

FDA - U.S. Food and Drug Administration

21-10-2018

We’re now moving to update/modernize our oversight to capitalize on a # of important advances, including the increased use of digital imaging, revised screening recommendations from the @CDCgov and need for uniform nation-wide breast density reporting  ht

We’re now moving to update/modernize our oversight to capitalize on a # of important advances, including the increased use of digital imaging, revised screening recommendations from the @CDCgov and need for uniform nation-wide breast density reporting ht

We’re now moving to update/modernize our oversight to capitalize on a # of important advances, including the increased use of digital imaging, revised screening recommendations from the @CDCgov and need for uniform nation-wide breast density reporting https://go.usa.gov/xPnyd .

FDA - U.S. Food and Drug Administration

21-10-2018

Under the 1992 Mammography Quality Standards Act (MQSA), #FDA oversees mammography machines and regulates training for people who provide the scans. All mammography facilities must be accredited, certified by FDA or a state certifier and inspected annuall

Under the 1992 Mammography Quality Standards Act (MQSA), #FDA oversees mammography machines and regulates training for people who provide the scans. All mammography facilities must be accredited, certified by FDA or a state certifier and inspected annuall

Under the 1992 Mammography Quality Standards Act (MQSA), #FDA oversees mammography machines and regulates training for people who provide the scans. All mammography facilities must be accredited, certified by FDA or a state certifier and inspected annually https://go.usa.gov/xPnyE  pic.twitter.com/dZzQuYXsJ9

FDA - U.S. Food and Drug Administration

21-10-2018

Although I’ve been focusing on medical products, we're also advancing our food safety and nutrition work, such as our joint advice w/ EPA on making informed choices about eating fish for women who are pregnant, may become pregnant or are breastfeeding  ht

Although I’ve been focusing on medical products, we're also advancing our food safety and nutrition work, such as our joint advice w/ EPA on making informed choices about eating fish for women who are pregnant, may become pregnant or are breastfeeding ht

Although I’ve been focusing on medical products, we're also advancing our food safety and nutrition work, such as our joint advice w/ EPA on making informed choices about eating fish for women who are pregnant, may become pregnant or are breastfeeding https://go.usa.gov/xPnda . pic.twitter.com/nktV9BDAC3

FDA - U.S. Food and Drug Administration

21-10-2018

Transparency is one way to encourage greater inclusion. Check out our Drug Trials Snapshots - information about who participated in clinical trials supporting a drug’s approval and whether there are any demographic differences in benefits or side effects

Transparency is one way to encourage greater inclusion. Check out our Drug Trials Snapshots - information about who participated in clinical trials supporting a drug’s approval and whether there are any demographic differences in benefits or side effects

Transparency is one way to encourage greater inclusion. Check out our Drug Trials Snapshots - information about who participated in clinical trials supporting a drug’s approval and whether there are any demographic differences in benefits or side effects https://go.usa.gov/xPnVQ . pic.twitter.com/MyoBPe0IGg

FDA - U.S. Food and Drug Administration

19-10-2018

New Safety Communication. @US_FDA   is sharing Updated Information To Reduce Potential Cardiac Surgery   Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems. Read More:  https://go.usa.gov/xPnNW  #FDA #MedicalDevice

New Safety Communication. @US_FDA is sharing Updated Information To Reduce Potential Cardiac Surgery Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems. Read More: https://go.usa.gov/xPnNW  #FDA #MedicalDevice

New Safety Communication. @US_FDA is sharing Updated Information To Reduce Potential Cardiac Surgery Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems. Read More: https://go.usa.gov/xPnNW  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

19-10-2018

#DYK: you shouldn’t wear deodorant, lotion or powder on the day of your mammogram. It may show up on the x-ray.  http://go.usa.gov/35cbh  #NationalMammographyDay

#DYK: you shouldn’t wear deodorant, lotion or powder on the day of your mammogram. It may show up on the x-ray. http://go.usa.gov/35cbh  #NationalMammographyDay

#DYK: you shouldn’t wear deodorant, lotion or powder on the day of your mammogram. It may show up on the x-ray. http://go.usa.gov/35cbh  #NationalMammographyDay

FDA - U.S. Food and Drug Administration

18-10-2018

THREAD: #FDA’s forthcoming proposal to update and modernize our mammography oversight is meant to capitalize on a number of important advances, including the need for more uniform, nation-wide breast density reporting:  https://go.usa.gov/xPRAm pic.twitte

THREAD: #FDA’s forthcoming proposal to update and modernize our mammography oversight is meant to capitalize on a number of important advances, including the need for more uniform, nation-wide breast density reporting: https://go.usa.gov/xPRAm pic.twitte

THREAD: #FDA’s forthcoming proposal to update and modernize our mammography oversight is meant to capitalize on a number of important advances, including the need for more uniform, nation-wide breast density reporting: https://go.usa.gov/xPRAm  pic.twitter.com/8cUIqr8l6x

FDA - U.S. Food and Drug Administration

17-10-2018

#FDA issues new draft guidance now open for comment: Content of Premarket Submissions for Management of Cybersecurity in #MedicalDevices. Click to read:  https://go.usa.gov/xPRNF pic.twitter.com/1VPpgHdbic

#FDA issues new draft guidance now open for comment: Content of Premarket Submissions for Management of Cybersecurity in #MedicalDevices. Click to read: https://go.usa.gov/xPRNF pic.twitter.com/1VPpgHdbic

#FDA issues new draft guidance now open for comment: Content of Premarket Submissions for Management of Cybersecurity in #MedicalDevices. Click to read: https://go.usa.gov/xPRNF  pic.twitter.com/1VPpgHdbic

FDA - U.S. Food and Drug Administration

17-10-2018

Mark Your Calendars: October 21 is Pink Ribbon Sunday! Wear pink to raise awareness about breast cancer and the value of mammograms:   http://go.usa.gov/xPkDE pic.twitter.com/IdHFDQ7dAW

Mark Your Calendars: October 21 is Pink Ribbon Sunday! Wear pink to raise awareness about breast cancer and the value of mammograms: http://go.usa.gov/xPkDE pic.twitter.com/IdHFDQ7dAW

Mark Your Calendars: October 21 is Pink Ribbon Sunday! Wear pink to raise awareness about breast cancer and the value of mammograms: http://go.usa.gov/xPkDE  pic.twitter.com/IdHFDQ7dAW

FDA - U.S. Food and Drug Administration

17-10-2018

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review.

Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD.  https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https://go.usa.gov/xPqku  pic.twitter.com/EYNZANlgr9

FDA - U.S. Food and Drug Administration

17-10-2018

Save the date & Join the @US_FDA’s  Patient Engagement Advisory Committee on Nov 15th to discuss  patient-generated health data from sources like social media, activity  trackers, and patient-driven registries. Learn more:  https://go.usa.gov/xPRau  #Digi

Save the date & Join the @US_FDA’s Patient Engagement Advisory Committee on Nov 15th to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. Learn more: https://go.usa.gov/xPRau  #Digi

Save the date & Join the @US_FDA’s Patient Engagement Advisory Committee on Nov 15th to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. Learn more: https://go.usa.gov/xPRau  #DigitalHealth #PEAC2018 pic.twitter.com/NU61Snpxxw

FDA - U.S. Food and Drug Administration

16-10-2018

#FDAapproves new drug for the treatment of breast cancer with certain gene mutations for adults:  https://go.usa.gov/xPNnH .pic.twitter.com/5mo0xuGCcK

#FDAapproves new drug for the treatment of breast cancer with certain gene mutations for adults: https://go.usa.gov/xPNnH .pic.twitter.com/5mo0xuGCcK

#FDAapproves new drug for the treatment of breast cancer with certain gene mutations for adults: https://go.usa.gov/xPNnH . pic.twitter.com/5mo0xuGCcK

FDA - U.S. Food and Drug Administration

15-10-2018

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to  https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevicespic.twitter.co

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevicespic.twitter.co

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevices pic.twitter.com/KBLIxo9CiV

FDA - U.S. Food and Drug Administration

13-10-2018

Get the facts about digital mammography:  https://go.usa.gov/xPkG7   BCAM18 #BreastCancer

Get the facts about digital mammography: https://go.usa.gov/xPkG7  BCAM18 #BreastCancer

Get the facts about digital mammography: https://go.usa.gov/xPkG7  BCAM18 #BreastCancer

FDA - U.S. Food and Drug Administration

11-10-2018

Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers: FDA Safety Communication  https://go.usa.gov/xPXRN  #fda #medicaldevice

Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers: FDA Safety Communication https://go.usa.gov/xPXRN  #fda #medicaldevice

Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers: FDA Safety Communication https://go.usa.gov/xPXRN  #fda #medicaldevice

FDA - U.S. Food and Drug Administration

10-10-2018

If you use a #MedicalDevice affected by a power outage caused by #HurricaneMichael, check out the #FDA’s tips for using a generator to restore power to your device:  https://go.usa.gov/xPjau pic.twitter.com/SLxGKzIIgc

If you use a #MedicalDevice affected by a power outage caused by #HurricaneMichael, check out the #FDA’s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau pic.twitter.com/SLxGKzIIgc

If you use a #MedicalDevice affected by a power outage caused by #HurricaneMichael, check out the #FDA’s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau  pic.twitter.com/SLxGKzIIgc

FDA - U.S. Food and Drug Administration

10-10-2018

As Hurricane #Michael nears land, take shelter & stay safe.

Follow weather updates on your phone or radio.

 In a tornado WARNING, go to an interior, windowless room.

 If water comes in, go to the highest floor that’s not flooded but do NOT enter a clos

As Hurricane #Michael nears land, take shelter & stay safe. Follow weather updates on your phone or radio. In a tornado WARNING, go to an interior, windowless room. If water comes in, go to the highest floor that’s not flooded but do NOT enter a clos

As Hurricane #Michael nears land, take shelter & stay safe. Follow weather updates on your phone or radio. In a tornado WARNING, go to an interior, windowless room. If water comes in, go to the highest floor that’s not flooded but do NOT enter a closed attic. pic.twitter.com/KD5WZ7gamP

FDA - U.S. Food and Drug Administration

9-10-2018

#ICYMI - FDA issues recommendations to help prevent surgical fires and      related patient injury. Click the link to read the recommendations:  https://go.usa.gov/xQdwG   #FirePreventionWeek #MedicalDevice

#ICYMI - FDA issues recommendations to help prevent surgical fires and related patient injury. Click the link to read the recommendations: https://go.usa.gov/xQdwG  #FirePreventionWeek #MedicalDevice

#ICYMI - FDA issues recommendations to help prevent surgical fires and related patient injury. Click the link to read the recommendations: https://go.usa.gov/xQdwG  #FirePreventionWeek #MedicalDevice

FDA - U.S. Food and Drug Administration

9-10-2018

Mammograms: Get the Facts.  http://go.usa.gov/xNGH8  #BCAMpic.twitter.com/dBRwahv5RW

Mammograms: Get the Facts. http://go.usa.gov/xNGH8  #BCAMpic.twitter.com/dBRwahv5RW

Mammograms: Get the Facts. http://go.usa.gov/xNGH8  #BCAM pic.twitter.com/dBRwahv5RW

FDA - U.S. Food and Drug Administration

5-10-2018

September 2018 PMA Approval List  https://go.usa.gov/xPkSh  #fda #medicaldevice

September 2018 PMA Approval List https://go.usa.gov/xPkSh  #fda #medicaldevice

September 2018 PMA Approval List https://go.usa.gov/xPkSh  #fda #medicaldevice

FDA - U.S. Food and Drug Administration

5-10-2018

Devices flag! The FDA has allowed the marketing a new type of hearing aid, a self-fitted hearing aid controlled by the user. Interested reporters should check out our press release:  https://go.usa.gov/xPkuB 

Devices flag! The FDA has allowed the marketing a new type of hearing aid, a self-fitted hearing aid controlled by the user. Interested reporters should check out our press release: https://go.usa.gov/xPkuB 

Devices flag! The FDA has allowed the marketing a new type of hearing aid, a self-fitted hearing aid controlled by the user. Interested reporters should check out our press release: https://go.usa.gov/xPkuB 

FDA - U.S. Food and Drug Administration

1-10-2018

My statement on the #FDA’s new efforts to strengthen the agency’s medical device cybersecurity program as part of our mission to protect patients  http://go.usa.gov/xPBK2 pic.twitter.com/8w5m5itceW

My statement on the #FDA’s new efforts to strengthen the agency’s medical device cybersecurity program as part of our mission to protect patients http://go.usa.gov/xPBK2 pic.twitter.com/8w5m5itceW

My statement on the #FDA’s new efforts to strengthen the agency’s medical device cybersecurity program as part of our mission to protect patients http://go.usa.gov/xPBK2  pic.twitter.com/8w5m5itceW

FDA - U.S. Food and Drug Administration

1-10-2018

National Cybersecurity Awareness Month has begun. This week’s theme is “Strengthening the Cybersecurity Ecosystem.” Click the link to learn more about #NCSAM:  https://go.usa.gov/xPZqb  #FDA #MedicalDevicespic.twitter.com/qOMDykqcxP

National Cybersecurity Awareness Month has begun. This week’s theme is “Strengthening the Cybersecurity Ecosystem.” Click the link to learn more about #NCSAM: https://go.usa.gov/xPZqb  #FDA #MedicalDevicespic.twitter.com/qOMDykqcxP

National Cybersecurity Awareness Month has begun. This week’s theme is “Strengthening the Cybersecurity Ecosystem.” Click the link to learn more about #NCSAM: https://go.usa.gov/xPZqb  #FDA #MedicalDevices pic.twitter.com/qOMDykqcxP

FDA - U.S. Food and Drug Administration

30-9-2018

Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied.  Selected applications will be announced in November. For more information about the challenge, click the link:   https://go.usa.gov/xP4Nk pic.twi

Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied. Selected applications will be announced in November. For more information about the challenge, click the link: https://go.usa.gov/xP4Nk pic.twi

Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied. Selected applications will be announced in November. For more information about the challenge, click the link: https://go.usa.gov/xP4Nk  pic.twitter.com/pFJZ39oGJC

FDA - U.S. Food and Drug Administration

29-9-2018

Reminder: the last day to submit applications to the #FDAInnovationChallenge is tomorrow, September 30th. Click the link to find out more about the challenge and how to submit your application:  https://go.usa.gov/xP4Nk pic.twitter.com/lLYiMa0cLe

Reminder: the last day to submit applications to the #FDAInnovationChallenge is tomorrow, September 30th. Click the link to find out more about the challenge and how to submit your application: https://go.usa.gov/xP4Nk pic.twitter.com/lLYiMa0cLe

Reminder: the last day to submit applications to the #FDAInnovationChallenge is tomorrow, September 30th. Click the link to find out more about the challenge and how to submit your application: https://go.usa.gov/xP4Nk  pic.twitter.com/lLYiMa0cLe

FDA - U.S. Food and Drug Administration

27-9-2018

We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin

We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin

We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin https://go.usa.gov/xPWZq  pic.twitter.com/LT9SptJge1

FDA - U.S. Food and Drug Administration

27-9-2018

Read about how the FDA is seeking more resources in FY2019 to help  advance our #FDAPrecert model for #DigitalHealth-modernizing our regulatory approach to help innovate digital health technologies, while  protecting patients. Click here:  https://go.usa.

Read about how the FDA is seeking more resources in FY2019 to help advance our #FDAPrecert model for #DigitalHealth-modernizing our regulatory approach to help innovate digital health technologies, while protecting patients. Click here: https://go.usa.

Read about how the FDA is seeking more resources in FY2019 to help advance our #FDAPrecert model for #DigitalHealth-modernizing our regulatory approach to help innovate digital health technologies, while protecting patients. Click here: https://go.usa.gov/xPWZ3  #mobilehealth

FDA - U.S. Food and Drug Administration

26-9-2018

#DYK that condoms are considered #MedicalDevices? Click the link to learn more about the #FDA’s role in regulating contraceptive devices to protect your sexual health:  https://go.usa.gov/xPDQw 

#DYK that condoms are considered #MedicalDevices? Click the link to learn more about the #FDA’s role in regulating contraceptive devices to protect your sexual health: https://go.usa.gov/xPDQw 

#DYK that condoms are considered #MedicalDevices? Click the link to learn more about the #FDA’s role in regulating contraceptive devices to protect your sexual health: https://go.usa.gov/xPDQw 

FDA - U.S. Food and Drug Administration

26-9-2018

The single-use internal condom (formerly the single-use female condom) is the only female-controlled barrier method intended to provide protection against pregnancy & STI transmission. Check out the FDA's birth control guide:  https://go.usa.gov/xPDQw  #M

The single-use internal condom (formerly the single-use female condom) is the only female-controlled barrier method intended to provide protection against pregnancy & STI transmission. Check out the FDA's birth control guide: https://go.usa.gov/xPDQw  #M

The single-use internal condom (formerly the single-use female condom) is the only female-controlled barrier method intended to provide protection against pregnancy & STI transmission. Check out the FDA's birth control guide: https://go.usa.gov/xPDQw  #MedicalDevices

FDA - U.S. Food and Drug Administration

26-9-2018

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application:   http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/Zsmq00NCdd

FDA - U.S. Food and Drug Administration

25-9-2018

Conducting clinical trials & preparing a submission for #FDA review?

Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more!  https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.usa.gov/xPqku . pic.twitter.com/Ktqq9Slx0y

FDA - U.S. Food and Drug Administration

25-9-2018

We hope this extra time will allow stakeholders to continue to provide  input on the ideas shared during the two-day Pediatric Device  Development public meeting held last month. #devices4kids https://go.usa.gov/xPjwd 

We hope this extra time will allow stakeholders to continue to provide input on the ideas shared during the two-day Pediatric Device Development public meeting held last month. #devices4kids https://go.usa.gov/xPjwd 

We hope this extra time will allow stakeholders to continue to provide input on the ideas shared during the two-day Pediatric Device Development public meeting held last month. #devices4kids https://go.usa.gov/xPjwd 

FDA - U.S. Food and Drug Administration

25-9-2018

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices:  http

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices: http

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices: https://go.usa.gov/xPjCj  pic.twitter.com/yVSNlc5Qb0

FDA - U.S. Food and Drug Administration

24-9-2018

#FDA announces the release of the Collaborative Communities Toolkit for interested stakeholder organizations to work together on healthcare challenges. Learn about the program, download the Toolkit, and submit comments:  https://go.usa.gov/xPjKX pic.twitt

#FDA announces the release of the Collaborative Communities Toolkit for interested stakeholder organizations to work together on healthcare challenges. Learn about the program, download the Toolkit, and submit comments: https://go.usa.gov/xPjKX pic.twitt

#FDA announces the release of the Collaborative Communities Toolkit for interested stakeholder organizations to work together on healthcare challenges. Learn about the program, download the Toolkit, and submit comments: https://go.usa.gov/xPjKX  pic.twitter.com/iQsKIAAQTn

FDA - U.S. Food and Drug Administration

24-9-2018

If you use a #MedicalDevice affected by a power outage caused by #HurricaneFlorence, check out the #FDA’s tips for using a generator to restore power to your device:  https://go.usa.gov/xPjau pic.twitter.com/z8SW2mlb86

If you use a #MedicalDevice affected by a power outage caused by #HurricaneFlorence, check out the #FDA’s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau pic.twitter.com/z8SW2mlb86

If you use a #MedicalDevice affected by a power outage caused by #HurricaneFlorence, check out the #FDA’s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau  pic.twitter.com/z8SW2mlb86

FDA - U.S. Food and Drug Administration

24-9-2018

For more information about the #FDA’s effort to address the epidemic of  #opioid addiction, click the link to find out more about the  #FDAInnovationChallenge:  https://go.usa.gov/xPja7  The last day to submit  applications is September 30th, 2018.https:/

For more information about the #FDA’s effort to address the epidemic of #opioid addiction, click the link to find out more about the #FDAInnovationChallenge: https://go.usa.gov/xPja7  The last day to submit applications is September 30th, 2018.https:/

For more information about the #FDA’s effort to address the epidemic of #opioid addiction, click the link to find out more about the #FDAInnovationChallenge: https://go.usa.gov/xPja7  The last day to submit applications is September 30th, 2018. https://twitter.com/NIDAnews/status/1032719474934382593 …

FDA - U.S. Food and Drug Administration

21-9-2018

Click the link for a handy list of #FDA’s recommendations for using and  caring for your medical devices during a #hurricane.   https://go.usa.gov/xPbgc  #MedicalDevice

Click the link for a handy list of #FDA’s recommendations for using and caring for your medical devices during a #hurricane. https://go.usa.gov/xPbgc  #MedicalDevice

Click the link for a handy list of #FDA’s recommendations for using and caring for your medical devices during a #hurricane. https://go.usa.gov/xPbgc  #MedicalDevice

FDA - U.S. Food and Drug Administration

21-9-2018

#DYK #hurricane season is active through November. Be prepared & stay informed of #MedicalDevice safety. Click the link to find a useful planning booklet from the #FDA that can help u prepare & handle power outages for medical devices that use electricity

#DYK #hurricane season is active through November. Be prepared & stay informed of #MedicalDevice safety. Click the link to find a useful planning booklet from the #FDA that can help u prepare & handle power outages for medical devices that use electricity

#DYK #hurricane season is active through November. Be prepared & stay informed of #MedicalDevice safety. Click the link to find a useful planning booklet from the #FDA that can help u prepare & handle power outages for medical devices that use electricity: https://go.usa.gov/xPbYt 

FDA - U.S. Food and Drug Administration

19-9-2018

As people return home and businesses begin to reopen, #FDA is committed to providing safety tips for the general public and technical assistance for businesses, such as advice on Restaurants and Grocers Reopening After Hurricanes and Flooding:  https://go

As people return home and businesses begin to reopen, #FDA is committed to providing safety tips for the general public and technical assistance for businesses, such as advice on Restaurants and Grocers Reopening After Hurricanes and Flooding: https://go

As people return home and businesses begin to reopen, #FDA is committed to providing safety tips for the general public and technical assistance for businesses, such as advice on Restaurants and Grocers Reopening After Hurricanes and Flooding: https://go.usa.gov/xP2y6  pic.twitter.com/r3c0i4pose

FDA - U.S. Food and Drug Administration

19-9-2018

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin  containing medical devices and device-led combination products to help  reduce the risk of patient injury. To read the guidance, click here:  https://go.usa.gov/x

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin containing medical devices and device-led combination products to help reduce the risk of patient injury. To read the guidance, click here: https://go.usa.gov/x

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin containing medical devices and device-led combination products to help reduce the risk of patient injury. To read the guidance, click here: https://go.usa.gov/xP2VB  #MedicalDevice pic.twitter.com/hsdX5ylKPu

FDA - U.S. Food and Drug Administration

19-9-2018

Reminder: #FDA site visit proposal solicitation period for the 2018  Experiential Learning Program is currently OPEN through Wednesday,  9/26/18 @ 12 pm EST. Click the link to find more about the  program & to submit your application  https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/FN1mNN65dD

FDA - U.S. Food and Drug Administration

17-9-2018

We had lots of great questions from potential applicants during our recent webinar. Check out the recording for Q&A about the #FDAInnovationChallenge. Click the link for the webinar recording:  https://go.usa.gov/xP4N5  #FDA #MedicalDevices

We had lots of great questions from potential applicants during our recent webinar. Check out the recording for Q&A about the #FDAInnovationChallenge. Click the link for the webinar recording: https://go.usa.gov/xP4N5  #FDA #MedicalDevices

We had lots of great questions from potential applicants during our recent webinar. Check out the recording for Q&A about the #FDAInnovationChallenge. Click the link for the webinar recording: https://go.usa.gov/xP4N5  #FDA #MedicalDevices

FDA - U.S. Food and Drug Administration

17-9-2018

Visit our webpage for more information:  https://go.usa.gov/xP4Nk pic.twitter.com/juX1wEGMBk

Visit our webpage for more information: https://go.usa.gov/xP4Nk pic.twitter.com/juX1wEGMBk

Visit our webpage for more information: https://go.usa.gov/xP4Nk  pic.twitter.com/juX1wEGMBk

FDA - U.S. Food and Drug Administration

14-9-2018

Federal Register Notice: #FDA Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee. Nominations are due by November 5, 2018. For more information, click here:  https://go.usa.g

Federal Register Notice: #FDA Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee. Nominations are due by November 5, 2018. For more information, click here: https://go.usa.g

Federal Register Notice: #FDA Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee. Nominations are due by November 5, 2018. For more information, click here: https://go.usa.gov/xPgW5  #MedicalDevice

FDA - U.S. Food and Drug Administration

14-9-2018

Federal Register Notice: Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee. Nominations are due by October 9, 2018. For more information, click here:  https://go.usa.gov/xPgWa  #MedicalDevice

Federal Register Notice: Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee. Nominations are due by October 9, 2018. For more information, click here: https://go.usa.gov/xPgWa  #MedicalDevice

Federal Register Notice: Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee. Nominations are due by October 9, 2018. For more information, click here: https://go.usa.gov/xPgWa  #MedicalDevice

FDA - U.S. Food and Drug Administration