Xenon Air Liquide Medical

Hauptinformation

  • Handelsname:
  • Xenon Air Liquide Medical Inhalationsgas 100% (v-v)
  • Dosierung:
  • 100% (v-v)
  • Darreichungsform:
  • Inhalationsgas
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

  • Information für medizinisches Fachpersonal:
  • Das Informationsblatt für dieses Produkt ist derzeit nicht verfügbar, können Sie eine Anfrage an unseren Kundendienst zu senden und wir werden Sie benachrichtigen, sobald wir in der Lage, um es zu erhalten.


    Fordern Sie die Packungsbeilage für medizinisches Fachpersonal.

Lokalisierung

  • Erhältlich in:
  • Xenon Air Liquide Medical Inhalationsgas 100% (v-v)
    Belgien
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • andere Allgemeine Anästhetika

Weitere Informationen

Status

  • Quelle:
  • AFMPS - Agence Fédérale des Médicaments et des Produits de Santé - Belgium
  • Zulassungsnummer:
  • BE344601
  • Letzte Änderung:
  • 13-04-2018

Packungsbeilage

PACKUNGSBEILAGE

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GEBRAUCHSINFORMATION: INFORMATION FÜR ANWENDER

Xenon AIR LIQUIDE Medical 100 % (v/v) medizinisches Gas, verflüssigt, zur Inhalation

Xenon

Lesen Sie die gesamte Packungsbeilage sorgfältig durch, bevor Sie mit der Anwendung dieses

Arzneimittels beginnen.

Heben Sie die Packungsbeilage auf. Vielleicht möchten Sie diese später nochmals lesen.

Wenn Sie weitere Fragen haben, wenden Sie sich an Ihren Arzt.

Dieses Arzneimittel wurde Ihnen persönlich verschrieben. Geben Sie es nicht an Dritte weiter. Es kann

anderen Menschen schaden, auch wenn diese die gleichen Beschwerden haben wie Sie.

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt. Dies gilt auch für

Nebenwirkungen, die nicht in dieser Packungbeilage angegeben sind. Siehe Abschnitt 4.

Was in dieser Packungsbeilage steht:

Was ist Xenon AIR LIQUIDE Medical und wofür wird es angewendet?

Was sollten Sie vor der Anwendung von Xenon AIR LIQUIDE Medical beachten?

Wie ist Xenon AIR LIQUIDE Medical anzuwenden?

Welche Nebenwirkungen sind möglich?

Wie ist Xenon AIR LIQUIDE Medical aufzubewahren?

Inhalt der Packung und weitere Informationen

1.

WAS IST Xenon AIR LIQUIDE Medical UND WOFÜR WIRD ES ANGEWENDET?

Xenon AIR LIQUIDE Medical ist ein teilverflüssigtes Gas zur allgemeinen Inhalationsanästhesie.

Xenon AIR LIQUIDE Medical eignet sich zur Aufrechterhaltung einer Narkose in Kombination mit

Opioiden im Rahmen einer Allgemeinästhesie bei Erwachsenen.

2.

WAS SOLLTEN SIE VOR DER ANWENDUNG VON Xenon AIR LIQUIDE Medical

BEACHTEN?

Xenon AIR LIQUIDE Medical darf nicht angewendet werden,

wenn Sie gegen Xenon allergisch sind;

Wenn bei Ihnen ein Verdacht auf maligne Hyperthermie (ein schneller und schädlicher Anstieg der

Körpertemperatur während eines chirurgischen Eingriffs oder kurz danach) besteht;

Wenn Sie:

erhöhten Schädelinnendruck haben,

während der Schwangerschaft an plötzlichem Blutdruckanstieg mit oder ohne Krampf leiden,

an einer Lungen- und/oder Atemwegserkrankung leiden,

an deutlich unzureichender Herzfunktion (Herzschwäche) leiden,

wenn Sie jünger als 18 Jahre sind;

wenn Ihre Krankheit einer Beatmung mit hohen Sauerstoffkonzentration bedarf.

Warnhinweise und Vorsichtsmaßnahmen

Bitte informieren Sie Ihren Narkosearzt in folgenden Fällen, damit er bei der medizinischen Anwendung

von Xenon AIR LIQUIDE Medical besondere Vorsicht walten lässt:

Wenn Sie unter Bluthochdruck leiden;

wenn Sie Leber- und / oder Nierenerkrankungen haben,

wenn Sie ein erhöhtes Risikio der postoperative Übelkeit und Erbrechen haben .

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Anwendung von Xenon AIR LIQUIDE Medical mit anderen Arzneimitteln

In den meisten Fällen besteht kein Grund, vor einer Allgemeinanästhesie mit Xenon die Behandlung mit

anderen Arzneimitteln abzusetzen. Bitte informieren sie Ihren Arzt über alle laufenden Behandlungen mit

Arzneimitteln .

Insbesondere muss Ihr Arzt informiert werden, wenn Sie folgende Arzneimittel einnehmen:

auf das Nervensystem wirkende Arzneimittel (Amphetamine und deren Derivate, Psychostimulantien,

Appetitzügler, Ephedrin und dessen Derivate z.B bei nasalen Anwendung), es kann empfohlen werden

sie einige Tage vor der Operation abzusetzen;

Bestimmte Antidepressiva Monoaminooxidase-Hemmer (MAOI), eine Klasse von Antidepressiva, da sie

15 Tage vor der Operation abgesetzt werden sollten;

bestimmte Medikamente gegen Schmerzen oder Fieber (Opioide oder andere), da sie die narkotische

Wirkung von Xenon AIR LIQUIDE Medical verstärken können;

alle Bluthochdruckmittel, auch wenn die Behandlung damit nicht abgebrochen werden sollte.

Bitte informieren Sie Ihren Anästhesisten, wenn Sie andere Arzneimittel verwenden oder vor kurzem

verwendet haben, auch wenn es sich um nicht verschreibungspflichtige Arzneimittel handelt.

Schwangerschaft und Stillzeit

Bei der Entscheidung über die Verwendung von Xenon AIR LIQUIDE Medical während der Stillzeit müssen

die Vorteile des Stillens für das Kind auf der einen Seite und diejenigen einer Xenon-Narkose für die Frau

gegeneinander abgewogen werden.

Bitte informieren Sie Ihren Anästhesisten, wenn Sie schwanger sind oder die Wahrscheinlichkeit einer

Schwangerschaft besteht oder wenn Sie stillen. Diese Information ist wichtig bei der Entscheidung, ob dieses

Arzneimittel für Sie geeignet ist.

Die Anwendung von Xenon AIR LIQUIDE Medical während der Schwangerschaft wird nicht empfohlen.

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen

Wie alle Anästhetika hat Xenon großen Einfluss auf die Verkehrstüchtigkeit und das Bedienen von

Maschinen.

Daher dürfen Sie sich nach einer Narkose mit Xenon nicht ans Steuer eines Kraftfahrzeuges setzen und keine

Maschinen bedienen. Über die entsprechende Zeitspanne hat der Arzt individuell zu entscheiden.

Sie Sollten sich nicht allein nach Hause begeben, sondern müssen begleitet werden..

Trinken sie keinen Alkohol.

3.

WIE IST Xenon AIR LIQUIDE Medical ANZUWENDEN?

Xenon AIR LIQUIDE Medical wird durch einen Anästhesisten angewendet, der die erforderliche Dosis

entsprechend Ihres individuellen Bedarfs, der Art der Operation und anderer während des Eingriffs

verabreichter Arzneimittel bestimmt.

Die Beatmung mit Xenon darf nur unter zusätzlicher Sauerstoffdosierung vorgenommen werden.

Die Anwendungsdauer richtet sich nach der Dauer der Narkose.

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Anwendung bei Kindern

Xenon AIR LIQUIDE Medical darf nicht angewendet werden, wenn Sie Jünger als 18 Jahre sind.

Wenn Sie weitere Fragen zur Anwendung dieses Arzneimittels haben, fragen Sie bitte Ihren Arzt.

Wenn Sie eine gröβere Menge von Xenon AIR LIQUIDE Medicinal angewendet haben, als Sie solten

Wenn Sie zu viel Xenon AIR LIQUIDE Medical angewendet haben, verständigen Sie sich unverzüglich ihres

Arzt, Ihrem Apotheker oder den Giftnotruf (070/245.245).

4.

WELCHE NEBENWIRKUNGEN SIND MÖGLICH?

Wie alle Arzneimittel kann Xenon AIR LIQUIDE Medical Nebenwirkungen haben, die aber nicht bei jedem

auftreten müssen.

Da Xenon ausschließlich durch den Anästhesisten verabreicht wird, wird dieser bei Auftreten von

Nebenwirkungen entscheiden, ob diese symptomatisch behandelt werden oder ob die Xenon-Anästhesie

unterbrochen wird.

Xenon AIR LIQUIDE Medical führt wie andere Inhalationsanästhetika konzentrationsabhängig zu mehr oder

weniger Atemdepression.

Sehr häufige Nebenwirkungen (bei mehr als 1 von 10 Behandelten):

Hypertension (Bluthochdruck)

Postoperative Übelkeit und Erbrechen (bis zu 45% der Fälle)

Häufige Nebenwirkungen (bei weniger als 1 von 10 Behandelten):

Temperaturerhöhung oder Schwitzen während und nach der Operation

Frösteln

Bradykardie (verlangsamter Herzschlag)

Hypotension (erniedrigter Blutdruck)

Sehr seltene Nebenwirkungen (bei weniger als 1 von 10 000 Behandelten):

Bronchialspasmus (Krampf der Bronchialmuskulatur)

Weiterhin wurden in klinischen Studien folgende Ereignisse beobachtet, ohne in einen direkten

Zusammenhang zur Xenon-Anästhesie gebracht worden zu sein:

Arrhythmie (Herzschlag)

Anstieg von Leberenzymen (große Menge von in der Leber produzierten Stoffen)

Renale Dysfunktion (Nierenfunktionsstörung)

Hypersekretion (vermehrte Drüsenausscheidung)

Hypokalzämie (erniedrigter Kalziumspiegel)

Hyperleukozytose (vermehrte Zahl der roten Blutkörperchen)

Metabolische Azidose (stoffelwechselbedingte Übersäuerung)

Tachykardie (Steigerung des Herzschlages)

Meldung von Nebenwirkungen

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt. Dies gilt auch für Nebenwirkungen,

die nicht in dieser Packungsbeilage angegeben sind.

Sie können Nebenwirkungen auch direkt über * anzeigen :

* Föderalagentur für Arzneimittel und Gesundheitsprodukte

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Abteilung Vigilanz

EUROSTATION II

Victor Hortaplein, 40/40

B-1060 BRUSSEL

Website: www.fagg-afmps.be

E-Mail: patientinfo@fagg-afmps.be

Indem Sie Nebenwirkungen melden, können Sie dazu beitragen, dass mehr Informationen über die Sicherheit

dieses Arzneimittels zur Verfügung gestellt werden.

5.

WIE IST Xenon AIR LIQUIDE Medical AUFZUBEWAHREN?

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

Sie dürfen dieses Arzneimittel nach dem auf dem Druckflaschenetikett angegebenen Verfalldatum nicht mehr

anwenden. Das Verfalldatum bezieht sich auf den letzten Tag des angegebenen Monats.

6.

INHALT DER PACKUNG UND WEITERE INFORMATIONEN

Was Xenon AIR LIQUIDE Medical,

enthält

Der Wirkstoff ist:

Xenon 100 % (v/v).

1 Liter Gas enthält unter Standardbedingungen (1,013 bar, 15°C) 1 Liter Xenon.

Sonstige Bestandteile: keine

Wie Xenon AIR LIQUIDE Medical, aussieht und Inhalt der Packung

Xenon AIR LIQUIDE Medical ist ein geruch - und farbloses medizinisches Gas zur Inhalation, erhältlich in

2 Liter-, 5 Liter- und 10 Liter-Behältern) mit entweder 233 Litern, 555 Litern oder 1 000 Litern Xenon.

Pharmazeutischer Unternehmer und Hersteller

Pharmazeutischer Unternehmer:

AIR LIQUIDE Santé INTERNATIONAL

75, Quai d’Orsay

F-75007 PARIS

Frankreich

Örtlicher Vertreter :

Air Liquide Medical, Quai des Vennes, 8 B-4020 Liège, Belgien TEL : 0032 (0)2/255.96.96

Hersteller:

AIR LIQUIDE Medical GmbH

Hans-Günther-Sohl-Str. 5

D-40235 Düsseldorf

Deutschland

Dieses Arzneimittel ist in den Mitgliedsstaaten des Europäischen Wirtschaftsraumes (EWR) unter den

folgenden Bezeichnungen zugelassen:

Belgien

Xenon AIR LIQUIDE Medical 100 % (v/v)

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Dänemark

LENOXe 100 % (v/v)

Deutschland

LENOXe 100 % (v/v)

Frankreich

LENOXe 100 % (v/v)

Italien

LENOXe 100 % (v/v)

Luxemburg

LENOXe 100 % (v/v)

Niederlande

LENOXe 100 % (v/v)

Österreich

LENOXe 100 % (V/V)

Portugal

LENOXe 100 % (v/v)

Schweden

LENOXe 100 % (v/v)

Spain

LENOXe 100 % (v/v)

Spanien

LENOXe 100 % (v/v)

Vereinigtes Königreich

Xenon Anaesthetic 100 % (v/v)

Verkaufabgrenzung:

Verschreibungspflichtig.

Nur für den Krankenhausgebrauch.

Zulassungsnummer:

BE344601

Diese Gebrauchsinformation wurde zuletzt genehmigt im 09/2014

Die folgenden Informationen sind nur für Ärzte bzw. medizinisches Fachpersonal bestimmt:

Die Behälter mit Xenon sind ausschließlich für den medizinischen Gebrauch bestimmt.

Die Verabreichung von Xenon muss von einem Anästhesisten überwacht werden, und dieser muss ein

zertifiziertes Narkosegerät benutzen.

VORSICHTSMASSNAHMEN BEI DER HANDHABUNG

Xenon darf nur im Gemisch mit mindestens 30% Sauerstoff angewendet werden – Ansonsten besteht

Erstickungsgefahr.

Xenon ist nicht zur Anwendung als Monoanästhetikum vorgesehen. Da der MAC-Wert 55-71 % (v/v)

beträgt, ist es unter einem normalen Umgebungsluftdruck bei ausreichender Oxygenierung nicht bei allen

Patienten möglich, eine Monoanästhesie mit Xenon durchzuführen. Aus diesem Grund wird Xenon

üblicherweise mit Opioiden kombiniert (balancierte Anästhesie). Bei Unsicherheit der Narkosetiefe,

insbesondere

erhöhten

inspiratorischen

Sauerstoffkonzentrationen

(>35%),

sollte

Anästhesieverfahren gewechselt werden.

Die Anwendung von Xenon bei neurologischen Operationen wird aufgrund des erhöhten zerebralen

Blutflusses unter Xenon und der fehlenden klinischen Daten derzeit nicht empfohlen.

Die physikalischen Eigenschaften von Xenon führen zu einem Anstieg des Atemwegdrucks.

Xenon hat eine niedrige Blutgaslöslichkeit. Daher kann das Risiko eines erhöhten Druckes in mit Luft

gefüllten Hohlräumen über die Zeit nicht ganz ausgeschlossen werden.

Zur Zeit wird eine gleichzeitige Anwendung von volatilen Anästhetika nicht empfohlen, da nur begrenzte

klinische Erfahrung und keine klinischen Daten vorliegen.

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Man beachte, dass Xenon schwerer als Luft ist, es könnte an niedrigen Stellen zum Ersticken führen, da

es die Luft verdrängt.

HINWEISE ZUR AUFBEWAHRUNG DES DRUCKGASBEHÄLTERS

Alle Vorschriften bezüglich der Handhabung von Druckbehältern müssen beachtet werden:

Originalbehältnis

aufbewahren:

nicht

Originaldruckgasbehälter

einen

anderen

Druckgasbehälter überführen.

Druckgasbehälter fest verschlossen halten.

Druckgasbehälter in gut durchlüfteten Räumen aufbewahren oder im Außenbereich in belüfteten

Lagerplätzen vor Regen und direktem Sonnenlicht geschützt.

Druckgasbehälter vor Stößen, Umfallen, oxidierendem und entzündlichem Material, Feuchtigkeit,

Quellen von Hitze oder Entzündung schützen.

Aufbewahrung in der Apotheke

Der Druckgasbehälter soll in einem belüfteten, sauberen, abgeschlossenem und zur Lagerung medizinischer

Gase dienenden Raum aufbewahrt werden. In diesem Raum sollte ein separater Platz nur zur Aufbewahrung

von Xenon-Druckgasbehältern vorgesehen sein.

Aufbewahrung in der medizinischen Abteilung

Der Druckgasbehälter sollte an einem geeigneten Platz mit entsprechender Ausrüstung, um ihn in vertikaler

Stellung zu halten, aufbewahrt werden.

HINWEISE ZUM TRANSPORT DES DRUCKGASBEHÄLTERS

Die Druckgasbehälter sollten nur mit der richtigen Ausrüstung transportiert werden, um sie vor dem

Umfallen oder unkontrollierter Entleerung zu schützen.

Während des Transports von Patienten innerhalb des Krankenhauses oder von Krankenhaus zu

Krankenhaus sollte der Druckgasbehälter in vertikaler Stellung gut befestigt aufbewahrt werden, um das

Risiko des Umfallens oder unkontrolliertem Entleeren zu vermeiden.

Eine besondere Aufmerksamkeit sollte der Befestigung des Druckgasbehälterventils gelten, um somit die

Risiken eines versehentlichen Versagens zu vermeiden.

HINWEISE ZUR BENUTZUNG UND HANDHABUNG DES DRUCKGASBEHÄLTERS

Unter einer Temperatur von 16,6°C liegt Xenon in zwei Phasen vor: flüssig und gasförmig. Über einer

Temperatur von 16,6°C gibt es nur eine gasförmige Phase.

Daher muss der Druckgasbehälter vor der Verwendung 24 Stunden bei Raumtemperatur gelagert

werden.

Die Installation eines Pipeline-Systems für Xenon mit Druckgasbehältervorratsstation, festen Verbindungen

und Abgabeeinheiten ist verboten!

Alle Vorschriften bezüglich der Handhabung von Druckgasbehältern müssen beachtet werden.

Um Unfälle zu vermeiden, müssen die folgenden Hinweise streng beachtet werden:

Alle Materialien sollten vor Gebrauch auf ihre Funktionsfähigkeit überprüft werden;

die Druckgasbehälter sollten an einem festen Standort, vor Umfallen geschützt, aufbewahrt werden;

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das Druckgasbehälterventil sollte nicht gewaltsam geöffnet werden;

ein Druckgasbehälter ohne Schutzkappe über dem Ventil sollte nicht verwendet werden;

ein spezieller Anschlu

gemäß DIN 477-1 und ein Druckminderer mit mindestens dem 1,5fachen

maximalen Arbeitsdruck (58,4 bar) des Druckgasbehälters sollte verwendet werden;

ein defektes Druckgasbehälterventil sollte nicht repariert werden;

der Druckminderer sollte nicht mit einer Zange angezogen werden, da das Risiko besteht, die Dichtung

zu zerstören.

am Ende des Anästesieverfahrens bitte sicherstellen, dass die Ventile geschlossen sind und der

Restdruck beibehalten wird.

VERBINDUNGEN ZUM AÄSTHESIESYSTEM

(Für Xenon-Anästhesien sind Zusatzspezifikationen erforderlich.)

Eine spezifische Gaseinlassverbing für Xenon gemäß der Norm EN 7.39: 1998 mit einem

Standardanschlussstutzen NIST B16;

anti-hypoxisches Kupplungssystem;

ein auf Xenon kalibrierter Gasmischer zur Sicherstellung einer adäquaten Dosierung von Xenon;

messung der Xenon-Konzentration im Atemkreislauf des Beatmungsgeräts durch einen speziellen

Sensor;

einen Analysator im Atemkreislauf des Geräts zur Überwachnung der Sauerstoffkonzentration im

Gemisch mit Xenon mit den erforderlichen, dem System angeschlossenen Alarmfunktionen

ausgestattet ist;

konventionelle Absaugung für ausgeatmetes Xenon.

HINWEISE ZUR ENTSORGUNG

Ein leerer Druckgasbehälter sollte nicht weggeworfen werden. Sie werden immer vom

pharmazeutischen Unternehmer zurückgenommen.

Zur Vermeidung von Kontamination und um eine einwandfreie Funktion nach Wiederbefüllung

sicherzustellen, dürfen die Druckgasbehälter nur bis zu einem Restdruck von 3 bar entleert werden.

Es müssen die notwendigen Vorkehrungen getroffen werden, um das Eindringen von Wasser,

Feuchtigkeit oder Fremdstoffen in die Behälter zu verhindern.

be-proposedtranslationde-DEH696001II009-pl-track

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FDA - U.S. Food and Drug Administration

9-10-2018

Essity Professional Hygiene North America LLC recalls Tork Foam Soap Extra Mild SKU

Essity Professional Hygiene North America LLC recalls Tork Foam Soap Extra Mild SKU

The recalled product is potentially contaminated with the bacteria Burkholderia cepacia. B. cepacia is found in soil and water and poses little medical risk to healthy people.

Health Canada

5-10-2018

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Today the New York State Department of Agriculture and Markets alerted consumers to a pasteurization problem with one of Sprout Creek Farm's pasteurized cow's milk cheeses, "Margie," made on 8/28/2018. Sprout Creek Farm is located in Poughkeepsie, NY. The reason for the recall is the air temperature at the start and end of the pasteurization process is required to be above 150deg F per the Grade "A" Pasteurized Milk Ordinance; the batch in question did not meet that standard. The recall pertains only to...

FDA - U.S. Food and Drug Administration

2-10-2018

"The environment has a real impact on the risk of cancer, although it remains difficult to assess": three questions for Professor Gérard Lasfargues, Managing Director General of the Science for Expertise Division

"The environment has a real impact on the risk of cancer, although it remains difficult to assess": three questions for Professor Gérard Lasfargues, Managing Director General of the Science for Expertise Division

Despite medical advances, cancer remains the leading cause of death in France.  While active smoking, alcohol consumption and an unbalanced diet continue to be the main causes of cancer mortality, the environment has a real impact on the risk of cancer, although it remains difficult to assess.

France - Agence Nationale du Médicament Vétérinaire

1-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s efforts to strengthen the agency’s medical device cybersecurity program as part of its mission to protect patients

Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s efforts to strengthen the agency’s medical device cybersecurity program as part of its mission to protect patients

FDA’s efforts to strengthen the agency’s medical device cybersecurity program as part of its mission to protect patients

FDA - U.S. Food and Drug Administration

28-9-2018

Drug agency from China visits Denmark

Drug agency from China visits Denmark

A delegation from the Centre for Drug Evaluation under the China National Medical Products Administration visited the Danish Medicines Agency this week to discuss clinical trials and drug monitoring, among other things. The meeting at the Danish Medicines Agency is part of a Danish-Chinese collaboration under the auspices of the China-Denmark Food and Drug Regulatory Cooperation Centre, which was established with the signing of a collaboration agreement in May of last year, and which aims to strengthen r...

Danish Medicines Agency

24-9-2018

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA has awarded 12 new clinical trial research grants to enhance the development of medical products for patients with rare diseases

FDA - U.S. Food and Drug Administration

19-9-2018

September 19, 2018: Springfield Doctor Sentenced for Illegally Sharing Patient Medical Files

September 19, 2018: Springfield Doctor Sentenced for Illegally Sharing Patient Medical Files

September 19, 2018: Springfield Doctor Sentenced for Illegally Sharing Patient Medical Files

FDA - U.S. Food and Drug Administration

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

FDA Releases Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings

FDA Releases Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings

CVM’s five-year action plan for supporting antimicrobial stewardship in veterinary settings builds upon the important steps CVM has taken to eliminate production uses of medically important antimicrobials.

FDA - U.S. Food and Drug Administration

12-9-2018

FDA awards five grants to advance the development of pediatric medical devices

FDA awards five grants to advance the development of pediatric medical devices

FDA has awarded grants to five Pediatric Device Consortia that will provide advice to innovators of children's medical devices

FDA - U.S. Food and Drug Administration

12-9-2018

Natural Disaster Preparedness and Response (Drugs)

Natural Disaster Preparedness and Response (Drugs)

The FDA reminds consumers to have an emergency plan and to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves and their pets during and after severe storms (tornados, hurricanes, blizzards) and other events that can result in power outages, flooding, or road and business closures.

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

22-10-2018

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Active substance: mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) - Centralised - Yearly update - Commission Decision (2018)6972 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

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

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

18-10-2018

#FDA is committed to supporting women’s health. We know mammography is an important tool for detecting breast cancer in its early, most treatable stages and an excellent example of the meaningful and positive impact of medical device innovations

#FDA is committed to supporting women’s health. We know mammography is an important tool for detecting breast cancer in its early, most treatable stages and an excellent example of the meaningful and positive impact of medical device innovations

#FDA is committed to supporting women’s health. We know mammography is an important tool for detecting breast cancer in its early, most treatable stages and an excellent example of the meaningful and positive impact of medical device innovations

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

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

12-10-2018

The 2nd week of National Cybersecurity Awareness Month is here! This  week’s theme: “Cybersecurity = A Cross-Cutting Challenge to Tackle  Together”. Learn more about #NCSAM at   https://www.dhs.gov/stopthinkconnect …. #FDA #MedicalDevicespic.twitter.com/H

The 2nd week of National Cybersecurity Awareness Month is here! This week’s theme: “Cybersecurity = A Cross-Cutting Challenge to Tackle Together”. Learn more about #NCSAM at https://www.dhs.gov/stopthinkconnect …. #FDA #MedicalDevicespic.twitter.com/H

The 2nd week of National Cybersecurity Awareness Month is here! This week’s theme: “Cybersecurity = A Cross-Cutting Challenge to Tackle Together”. Learn more about #NCSAM at https://www.dhs.gov/stopthinkconnect …. #FDA #MedicalDevices pic.twitter.com/H3rUbSyLPq

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

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

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

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

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

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

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

#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

19-9-2018

 Important medical event terms list version 21.0 (IME-List)

Important medical event terms list version 21.0 (IME-List)

Europe - EMA - European Medicines Agency

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

The #FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development and review of their device proposals to prevent and treat opioid u

The #FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development and review of their device proposals to prevent and treat opioid u

The #FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development and review of their device proposals to prevent and treat opioid use disorder. #FDA

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

14-9-2018

#FDA approves device for treatment of acute coronary artery perforations. Read more about the approval here:  https://go.usa.gov/xPgTA  #MedicalDevice

#FDA approves device for treatment of acute coronary artery perforations. Read more about the approval here: https://go.usa.gov/xPgTA  #MedicalDevice

#FDA approves device for treatment of acute coronary artery perforations. Read more about the approval here: https://go.usa.gov/xPgTA  #MedicalDevice

FDA - U.S. Food and Drug Administration

14-9-2018

#FDA MQSA: Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc. Read the report here:  http://go.usa.gov/xPgTB  #MedicalDevice

#FDA MQSA: Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc. Read the report here: http://go.usa.gov/xPgTB  #MedicalDevice

#FDA MQSA: Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc. Read the report here: http://go.usa.gov/xPgTB  #MedicalDevice

FDA - U.S. Food and Drug Administration

14-9-2018

#FDA awards five grants to advance the development of pediatric medical devices. Click the link to read more about the grants and the FDA's work to advance the development of pediatric #MedicalDevices:  http://go.usa.gov/xPg2A 

#FDA awards five grants to advance the development of pediatric medical devices. Click the link to read more about the grants and the FDA's work to advance the development of pediatric #MedicalDevices: http://go.usa.gov/xPg2A 

#FDA awards five grants to advance the development of pediatric medical devices. Click the link to read more about the grants and the FDA's work to advance the development of pediatric #MedicalDevices: http://go.usa.gov/xPg2A 

FDA - U.S. Food and Drug Administration

14-9-2018

#FDA's Dr. Binita Ashar provides a statement on continuing the agency’s commitment to studying breast implant safety. To read the statement, click the link:  https://go.usa.gov/xPg4C  #MedicalDevices

#FDA's Dr. Binita Ashar provides a statement on continuing the agency’s commitment to studying breast implant safety. To read the statement, click the link: https://go.usa.gov/xPg4C  #MedicalDevices

#FDA's Dr. Binita Ashar provides a statement on continuing the agency’s commitment to studying breast implant safety. To read the statement, click the link: https://go.usa.gov/xPg4C  #MedicalDevices

FDA - U.S. Food and Drug Administration

12-9-2018

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

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

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #FDA #MedicalDevice pic.twitter.com/Kyo5z44Os4

FDA - U.S. Food and Drug Administration