NO-SPA

24-1-2019

Perrigo Issues Allergy Alert For Simple Truth Organic Banana, Strawberry & Apple Puree With Nonfat Greek Yogurt

Perrigo Company, in coordination with The Kroger Company, is initiating a voluntary recall of one production lot of Simple Truth Organic Banana, Strawberry & Apple Fruit Puree with Nonfat Greek Yogurt (LOT L8159, best by 08/06/2019, produced in Spain) due to improper labeling that does not indicate the presence of milk, posing a potential risk to consumers with milk allergies.

FDA - U.S. Food and Drug Administration

22-1-2019

PurpleAir recalls PowerStream power supplies for PA-II and PA-II-SD air quality sensors

PurpleAir has received reports of thermal events (arcing, sparking, smoking) originating in the power supplies. The thermal event is limited to the power supply and not PurpleAir’s air sensors, but the arcing, sparking, and smoking may pose a risk of fire if combustible material is near the power supply when it experiences a thermal event. Discoloration can result on the surface where a power supply is mounted.

Health Canada

19-1-2019

Data sources on animal diseases: Country Card of Spain

Published on: Thu, 17 Jan 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspond...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Minister Bruno Bruins verwelkomt EMA in Nederland

De tijdelijke huisvesting voor het Europees Geneesmiddelen Agentschap (EMA) is klaar voor gebruik. Dit is een belangrijke stap in de verhuizing van het EMA naar Nederland. Het EMA brengt jaarlijks 36.000 bezoekers naar Nederland en zorgt voor de komst van vele bedrijven. Vandaag heeft minister Bruins de sleutel van het Spark-gebouw overgedragen aan EMA.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

18-12-2018

eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Madrid), Lexington - AZCA, Madrid, Spain, from 23/05/2019 to 24/05/2019

eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Madrid), Lexington - AZCA, Madrid, Spain, from 23/05/2019 to 24/05/2019

Europe - EMA - European Medicines Agency

11-12-2018

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Madrid, Spain, from 20/05/2019 to 22/05/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Madrid, Spain, from 20/05/2019 to 22/05/2019

Europe - EMA - European Medicines Agency

30-11-2018

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

Published on: Thu, 29 Nov 2018 This report presents the results of surveillance on transmissible spongiform encephalopathies (TSEs) in bovine animals, sheep, goats, cervids and other animal species, as well as genotyping in sheep, carried out in 2017 in the European Union (EU) according to Regulation (EC) 999/2001, and in Iceland, Norway and Switzerland. In total, 1,312,714 cattle were tested by the 28 EU Member States (MSs) which is a decrease of 3% compared with 2016; 18,526 were tested by the three n...

Europe - EFSA - European Food Safety Authority Publications

30-11-2018

Understanding ASF spread and emergency control concepts in wild boar populations using individual‐based modelling and spatio‐temporal surveillance data

Published on: Thu, 29 Nov 2018 African swine fever (ASF) infection is circulating in Eurasia since a decade within wild boar populations without a demonstrated vector host. Further the infection was recurrently translocated by spatio‐temporal dynamics that is incompatible with wild boar movement characteristics. Management actions are required in areas affected by ASF. Control measures address areas with recent focal introduction and areas with ASF circulating several seasons or endemic occurrence. In v...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Published on: Mon, 26 Nov 2018 The GMO Panel has previously assessed genetically modified (GM) soybean A2704‐12. This soybean was found to be as safe and nutritious as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 5 June 2018, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soybean A2704‐12 and to indicate whether the previous c...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Published on: Mon, 19 Nov 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Spain, for the pesticide active substance (EZ)‐1,3‐dichloropropene are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of (EZ)‐1,3‐dichloropropene ...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Sternochetus mangiferae

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Sternochetus mangiferae (Coleoptera: Curculionidae), a monophagous pest weevil whose larvae exclusively feed on mango seeds, whereas adults feed on mango foliage. S. mangiferae is a species with reliable methods available for identification. It is regulated in the EU by Council Directive 2000/29/EC where it is listed in Annex IIB as a harmful organism whose introduction into EU Protec...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s ongoing efforts to prevent foodborne outbreaks of <i>Cyclospora</i>

he safety of the American food supply is one of the U.S. Food and Drug Administration’s highest priorities. A key part of our work in this space focuses on implementing the principles and measures of the FDA Food Safety Modernization Act (FSMA). The actions directed by FSMA are designed to prevent foodborne illness and food safety problems from happening.

FDA - U.S. Food and Drug Administration

13-9-2018

Hoogste punt kern EMA-gebouw Zuidas

Aankomende week wordt het hoogste punt van de kern van de nieuwbouw voor het Europees Geneesmiddelenagentschap bereikt, dat heeft minister Bruins (Medische Zorg) aan de Tweede Kamer gemeld. Dit is een belangrijke mijlpaal in de verhuizing van het EMA naar Amsterdam als gevolg van de Brexit. In slechts anderhalf jaar tijd wordt een voor EMA op maat gemaakt kantoorgebouw met conferentiecentrum aan de Zuidas gerealiseerd. Voordat de nieuwbouw gereed is dient het EMA-personeel tijdelijke gehuisvest te worden...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

11-9-2018

Preparation of Dutch food consumption data for risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The availability of detailed and high‐quality food consumption data collected at an individual level is essential for assessing the exposure to potential risks in the food chain. During the years 2012–2016, the Dutch National Food Consumption Survey was conducted in the Netherlands as part of the EU Menu survey, following the EFSA 2009 guidance on ‘General principles for the collection of national food consumption data in the view of a pan‐European dietary s...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

Europe - EFSA - European Food Safety Authority Publications

21-8-2018

BMC USA Corp. recalls Timemachine 01 bicycles

Variations in tire dimension, tire pressure, head set play and ride load, can result in insufficient space between the front wheel and downtube, posing a fall hazard.

Health Canada

13-7-2018

Water Pik, Inc. Recalls Sonic-Fusion® Flossing Toothbrush Product for Possible Health Risk

Water Pik, Inc. is voluntarily recalling its Sonic-Fusion® flossing toothbrush because the charging base may overheat with localized melting and sparking, possibly causing fire, shock or burns. Water Pik, Inc. has received consumer reports of product malfunctioning in the U.S. The recall is applicable only to Sonic-Fusion® products. All other Waterpik® brand flossers and toothbrushes are not affected.

FDA - U.S. Food and Drug Administration

9-7-2018

SPACE 2018 - GB- programme

France - Agence Nationale du Médicament Vétérinaire

2-7-2018

Afspraken over passend vervoer personen met verward gedrag in Friesland en Drenthe

Staatssecretaris Blokhuis (Volksgezondheid, Welzijn en Sport) en minister Grapperhaus (Justitie en Veiligheid) hebben vandaag met samenwerkingspartners in de provincies Drenthe en Friesland een convenant ondertekend over passend vervoer voor personen met verward gedrag. Het doel van de afspraken is om die personen onder minder stressvolle omstandigheden te vervoeren. Daarnaast zetten partijen hun handtekening onder het verder ontwikkelen van  goede zorg en vervoer voor deze groep mensen en gaan ze intens...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

29-6-2018

Talking Rain® Voluntarily Recalls Sparkling Ice® Cherry Limeade in Response to Customer Complaints

Talking Rain® (the Company) is voluntarily recalling specific lot codes of bottles of its Sparkling Ice® Cherry Limeade beverage in response to a small number of customer complaints that reported an off-taste and off-odor of the affected product. The Company made the decision to recall the product out of an abundance of caution.

FDA - U.S. Food and Drug Administration

19-5-2018

Unauthorized Botox and other health products seized from Arshia Hair Salon and Spa in Toronto May Pose Serious Health Risks

Health Canada is advising Canadians that it has seized an unauthorized “Botox” product and other unauthorized health products from Arshia Hair Salon and Spa (6062A Yonge Street) in Toronto, ON, because they may pose serious health risks. These products may have been administered as injectable treatments for cosmetic purposes.

Health Canada

5-12-2018

Luxturna (Spark Therapeutics Ireland Ltd)

Luxturna (Active substance: voretigene neparvovec) - Centralised - Authorisation - Commission Decision (2018)7970 of Wed, 05 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4451

Europe -DG Health and Food Safety

19-11-2018

How we regulate this space is important. Consider, for example, a sensor that collects data to track a drug as it moves through the body after being ingested to promote compliance or monitor how a drug is working.

How we regulate this space is important. Consider, for example, a sensor that collects data to track a drug as it moves through the body after being ingested to promote compliance or monitor how a drug is working.

FDA - U.S. Food and Drug Administration

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

18-9-2018

Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, ‘histology-independent indications’ in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine develo...

Europe - EMA - European Medicines Agency

4-6-2018

Electronic submissions and data review

Information on activities within the electronic submissions space

Therapeutic Goods Administration - Australia