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20-9-2018

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Published on: Wed, 19 Sep 2018 00:00:00 +0200 The third Joint Meeting of the ECDC's Food‐ and Waterborne Disease and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network was held on 16 and 17 October 2017 in Parma. The meeting was constructed around the principle of ‘One health approach to collaborative response to foodborne disease outbreaks in EU/EEA’ and served as an opportunity for public health authorities and food safety/veterinary authorities to meet and exchange information on the...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

Contaminated valsartan has so far not caused an increased incidence of cancer cases in Denmark

Contaminated valsartan has so far not caused an increased incidence of cancer cases in Denmark

A Danish registry study has examined if the cancer incidence rate is higher among people treated with the blood pressure lowering medicine Valsartan, which due to the risk of contamination was recalled from the market in July 2018. The study concludes that no increased cancer incidence can be seen at present.

Danish Medicines Agency

12-9-2018

Application of data science in risk assessment and early warning

Application of data science in risk assessment and early warning

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The currently applied approaches, procedures and tools used for the identification of emerging risks vary greatly among Member States of the EU. EFSA established a structured approach for emerging risk identification that mainly consists of systematically searching, collecting, collating and analysing information and data. In addition, EFSA concluded that new methodologies and tools are needed to facilitate efficient and transparent sharing of data, knowledg...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of white willow (Salix alba) in food

Risk assessment of white willow (Salix alba) in food

Published on: Tue, 28 Aug 2018 00:00:00 +0200 This Technical Report contains a description of the activities within the work programme of the EU‐FORA Fellowship on the risk assessment of white willow in food. The bark of different varieties of willow has had a long history of medical use as a means to reduce fever and as a painkiller. Willow bark is also used in weight loss and sports performance food supplements. The labelling of these products usually does not mention any restrictions to the length of...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin due to Possible Microbial Contamination

Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin due to Possible Microbial Contamination

HelloLife, Inc. in Grand Rapids, MI is initiating a voluntary recall of four different products, Neuroveen, Respitrol, Thyroveev and Compulsin, within expiry, to the retail and consumer level due to possible microbial contamination. Neuroveen has been tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia. Compulsin has been identified as containing Burkholderia cepacia. Respitrol and Thyroveev are still pending bacterial identification. Each product being recalled...

FDA - U.S. Food and Drug Administration

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Published on: Mon, 27 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the Netherlands and co‐rapporteur Member State, Sweden, for the pesticide active substance carvone are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

King Bio Issues Voluntary Nationwide Recall of All Aqueous-Based Products for Human and Animal Use Due to Possible Microbial Contamination

King Bio Issues Voluntary Nationwide Recall of All Aqueous-Based Products for Human and Animal Use Due to Possible Microbial Contamination

King Bio is voluntarily recalling all of its aqueous-based products for human and animal use (see website link below), within expiry, to the consumer level due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

23-7-2018

Flowers Foods Issues Voluntary Recall on Mrs. Freshley’s and Other Brands of Swiss Rolls and Captain John Derst’s Old Fashioned Bread

Flowers Foods Issues Voluntary Recall on Mrs. Freshley’s and Other Brands of Swiss Rolls and Captain John Derst’s Old Fashioned Bread

As a precautionary measure, Flowers Foods, Inc. (NYSE: FLO) is voluntarily recalling Swiss Rolls sold under the brand names Mrs. Freshley’s, Food Lion, H-E-B, Baker’s Treat, Market Square, and Great Value, distributed nationwide, and Captain John Derst’s Old Fashioned Bread distributed in Alabama, Florida, Georgia, North Carolina, and South Carolina, due to the potential presence of Salmonella in an ingredient, whey powder. The ingredient recall was initiated by a third-party whey powder manufacturer and...

FDA - U.S. Food and Drug Administration

12-7-2018

FDA Investigating Potential Connection Between Diet and Cases of Canine Heart Disease

FDA Investigating Potential Connection Between Diet and Cases of Canine Heart Disease

FDA is alerting pet owners and veterinary professionals about reports of canine dilated cardiomyopathy (DCM) in dogs eating certain pet foods containing peas, lentils, other legume seeds, or potatoes as main ingredients.

FDA - U.S. Food and Drug Administration

21-6-2018

Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk

Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk

NOW Health Group, Inc. (NOW), of Bloomingdale, Illinois, is recalling its NOW Real Food® Zesty Sprouting Mix – Product Code 7271, Lot #3031259 and Lot #3038165 – because its primary ingredient, Crimson Clover Seeds, has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may b...

FDA - U.S. Food and Drug Administration

6-6-2018

FDA seeks permanent injunction against company selling unapproved hand sanitizers that claim to prevent infections from numerous pathogens

FDA seeks permanent injunction against company selling unapproved hand sanitizers that claim to prevent infections from numerous pathogens

FDA seeks permanent injunction against company selling unapproved hand sanitizers that claim to prevent infections from numerous pathogens

FDA - U.S. Food and Drug Administration

6-6-2018

CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope Corp.: Class I Recall - Due to Fluid Ingress that May Affect Device Operation and Interrupt or Delay Therapy

CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope Corp.: Class I Recall - Due to Fluid Ingress that May Affect Device Operation and Interrupt or Delay Therapy

Maquet Datascope Corp. is recalling the IABP due to a design issue that allows fluid (such as saline) to seep into the device. The fluid can cause corrosion of internal components such as the electronic circuit boards, and lead to device malfunction (e.g., sudden stops) which can cause a delay or interruption in therapy. Device failure may result in immediate and serious adverse health consequences, including death.

FDA - U.S. Food and Drug Administration

1-6-2018

Demulen 30 birth control pills: Packages containing broken or chipped pills

Demulen 30 birth control pills: Packages containing broken or chipped pills

Pfizer Canada Inc. has notified Health Canada that it has received complaints of broken or chipped pills involving Demulen 30, a prescription birth control pill. Health Canada has previously communicated on similar issues involving two other brands of birth control pills. Health Canada continues to remind women to check their packages of birth control pills and to report problems if they see them. If you notice anything unusual in the package, such as missing or damaged pills, you should return the packa...

Health Canada

23-5-2018

The FDA is Seeking Input on the Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs

The FDA is Seeking Input on the Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs

FDA’s CVM is evaluating the design of studies intended to support the standard of effectiveness for new animal drugs to prevent heartworm disease in dogs. The FDA is requesting public input on evaluating these products to assist in the potential development of alternative study designs.

FDA - U.S. Food and Drug Administration

19-5-2018

Hickory Harvest Recalls Certain Island Fruit Mix and Organic Nut Mix Products Because of Possible Health Risk

Hickory Harvest Recalls Certain Island Fruit Mix and Organic Nut Mix Products Because of Possible Health Risk

Hickory Harvest Foods of Akron, Ohio is voluntarily recalling specific lots due to the potential exposure to Listeria monocytogenes. Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, pregnant women, and others with weakened immune systems. Healthy individuals may experience short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea. Listeria infection can also cause miscarr...

FDA - U.S. Food and Drug Administration

9-5-2018

FDA seeks permanent injunctions against two stem cell clinics

FDA seeks permanent injunctions against two stem cell clinics

FDA is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval

FDA - U.S. Food and Drug Administration

1-5-2018

Do You Vape? See These Tips on How to Keep E-Liquids Away from Children

Do You Vape? See These Tips on How to Keep E-Liquids Away from Children

Accidentally touching or drinking e-liquids can be dangerous and even deadly for young children. So it’s important to handle and store these products carefully, to teach children to stay away from these products, and to be prepared for emergencies. Consider these tips.

FDA - U.S. Food and Drug Administration

14-3-2018

Is It a Cold or the Flu? Prevention, Symptoms, Treatments

Is It a Cold or the Flu? Prevention, Symptoms, Treatments

How to tell if you have a cold or the flu, and when to seek medical care.

FDA - U.S. Food and Drug Administration

7-10-2016

Experts for the European Pharmacopoeia's groups of experts and working parties

Experts for the European Pharmacopoeia's groups of experts and working parties

A very large part of the work related to the drafting of new monographs for the European Pharmacopoeia (EDQM) is carried out by external experts in 75 groups of experts and working parties. Experts for the groups are appointed for a period of three years, and the EDQM is now seeking experts for the period from 2017 to 2019.

Danish Medicines Agency

8-8-2016

Efficacy of emergency contraception may be reduced when taken with other medicines

Efficacy of emergency contraception may be reduced when taken with other medicines

Women seeking the Norlevo or Levodonna emergency contraceptives should be aware that the efficacy may be reduced when taken with other medicines.

Danish Medicines Agency

8-5-2015

Annual Pharmacovigilance Report 2014

Annual Pharmacovigilance Report 2014

In our annual pharmacovigilance report 2014, you can read about the development in the number of ADR reports, learn about various focus areas and the European collaboration in the pharmacovigilance area as well as see a selection of the ADR signals we processed in 2014, and much more.

Danish Medicines Agency

19-8-2018

Let's start this school year off right and buckle up safely. Check out our detailed graphics to see how:  http://go.usa.gov/xUmuC  #BackToSchoolpic.twitter.com/wLWUFFnP89

Let's start this school year off right and buckle up safely. Check out our detailed graphics to see how: http://go.usa.gov/xUmuC  #BackToSchoolpic.twitter.com/wLWUFFnP89

Let's start this school year off right and buckle up safely. Check out our detailed graphics to see how: http://go.usa.gov/xUmuC  #BackToSchool pic.twitter.com/wLWUFFnP89

FDA - U.S. Food and Drug Administration

13-8-2018

IMDRF consultation: Principles of labelling for medical devices and IVD medical devices

IMDRF consultation: Principles of labelling for medical devices and IVD medical devices

The IMDRF is seeking comments on a proposed guidance document

Therapeutic Goods Administration - Australia

13-8-2018

IMDRF consultation: Terminologies for categorised adverse event reporting

IMDRF consultation: Terminologies for categorised adverse event reporting

The IMDRF is seeking comments on a proposed document and its annexes

Therapeutic Goods Administration - Australia

12-8-2018

IMDRF consultation: Unique Device Identification system

IMDRF consultation: Unique Device Identification system

The IMDRF is seeking comments on a proposed guidance document and two information documents

Therapeutic Goods Administration - Australia

10-8-2018

Consultation: Boxed Warning guidance

Consultation: Boxed Warning guidance

The TGA is seeking comments on the proposed guidance for the use of Boxed Warnings for prescription medicines. Closing date: 31 August 2018

Therapeutic Goods Administration - Australia

9-8-2018

Consultation: Proposed therapeutic goods advertising code guidance

Consultation: Proposed therapeutic goods advertising code guidance

The TGA is seeking input from interested parties on the revised version of the guidance to support the Code. Closing date: 4 October 2018

Therapeutic Goods Administration - Australia

22-7-2018

We’re exploring ways to use umbrella regulation or seek authority to address new risks faster. We're pursuing ways to spur innovation in safer devices; creating a Breakthrough Devices-like path  https://bit.ly/2O43EqH  and providing streamlined paths for

We’re exploring ways to use umbrella regulation or seek authority to address new risks faster. We're pursuing ways to spur innovation in safer devices; creating a Breakthrough Devices-like path https://bit.ly/2O43EqH  and providing streamlined paths for

We’re exploring ways to use umbrella regulation or seek authority to address new risks faster. We're pursuing ways to spur innovation in safer devices; creating a Breakthrough Devices-like path https://bit.ly/2O43EqH  and providing streamlined paths for comparative safety claims pic.twitter.com/30wLydOAec

FDA - U.S. Food and Drug Administration

18-7-2018

HSCC announced today a new workstream, conducted under the Task Group, that will discuss and seek input on a software bill of materials (SBOM) for medical devices. SBOMs can ensure that users have better understanding of what software elements are in a me

HSCC announced today a new workstream, conducted under the Task Group, that will discuss and seek input on a software bill of materials (SBOM) for medical devices. SBOMs can ensure that users have better understanding of what software elements are in a me

HSCC announced today a new workstream, conducted under the Task Group, that will discuss and seek input on a software bill of materials (SBOM) for medical devices. SBOMs can ensure that users have better understanding of what software elements are in a medical device.

FDA - U.S. Food and Drug Administration

11-7-2018

Seebri Breezhaler (Novartis Europharm Limited)

Seebri Breezhaler (Novartis Europharm Limited)

Seebri Breezhaler (Active substance: glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4513 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2430/T/27

Europe -DG Health and Food Safety

2-7-2018

Statutory advisory committee vacancies

Statutory advisory committee vacancies

We are seeking expressions of interest for vacancies on the Statutory advisory committees. Closing date: 31 July 2018

Therapeutic Goods Administration - Australia

29-6-2018

Smoking among adolescents has declined but #ecigarette use is growing in popularity. See trends on teen #tobacco use and regulation efforts  http://bit.ly/1EE2lpG  via @TeenHealthGov

Smoking among adolescents has declined but #ecigarette use is growing in popularity. See trends on teen #tobacco use and regulation efforts http://bit.ly/1EE2lpG  via @TeenHealthGov

Smoking among adolescents has declined but #ecigarette use is growing in popularity. See trends on teen #tobacco use and regulation efforts http://bit.ly/1EE2lpG  via @TeenHealthGov

FDA - U.S. Food and Drug Administration

25-5-2018

CDC wants to see your #SunSafeSelfie! Photograph yourself with protections such as sunglasses, a hat, long-sleeves & sunscreen and share your pic on social media:  https://goo.gl/jr1nP7 pic.twitter.com/hKJbKLnwni

CDC wants to see your #SunSafeSelfie! Photograph yourself with protections such as sunglasses, a hat, long-sleeves & sunscreen and share your pic on social media: https://goo.gl/jr1nP7 pic.twitter.com/hKJbKLnwni

CDC wants to see your #SunSafeSelfie! Photograph yourself with protections such as sunglasses, a hat, long-sleeves & sunscreen and share your pic on social media: https://goo.gl/jr1nP7  pic.twitter.com/hKJbKLnwni

FDA - U.S. Food and Drug Administration

24-5-2018

Consultation:  miconazole and fluconazole: proposed advisory statements for medicines

Consultation: miconazole and fluconazole: proposed advisory statements for medicines

The TGA is seeking comments on the proposed RASML statements for OTC medicines containing miconazole or fluconazole. Closing date: 21 June 2018

Therapeutic Goods Administration - Australia

24-5-2018

Consultation: Sedating antihistamines: proposed additional advisory statements for medicines

Consultation: Sedating antihistamines: proposed additional advisory statements for medicines

The TGA is seeking comments on the proposed RASML statements for OTC medicines containing sedating antihistamines. Closing date: 21 June 2018

Therapeutic Goods Administration - Australia