Blog
RSS FeedPosted by Michael Wonder on 07 Mar 2019
Many local governments shrug off FDA warning about Canadian drug imports
7 March 2019 - Cities and local governments in several states said they will continue to use a Canadian company ...
Posted by Michael Wonder on 12 Feb 2019
Statement from FDA Commissioner on ongoing efforts to stop the spread of illicit opioids, further secure the U.S. drug supply chain and forcefully confront opioid epidemic
12 February 2019 - The opioid epidemic continues to be one of the greatest challenges facing this nation and the FDA. ...
Posted by Michael Wonder on 11 Feb 2019
Fake drugs could put patients at risk after no-deal Brexit
8 February 2019 - Patients could be put at risk from fake medicines if the UK exits the EU without ...
Posted by Michael Wonder on 08 Feb 2019
New safety features for medicines sold in the EU
8 February 2019 - As of 9 February 2019, most prescription medicines and some over-the-counter medicines for human use supplied ...
Posted by Michael Wonder on 08 Feb 2019
FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain through innovations that improve tracking and tracing of medicines
7 February 2019 - A key element of the U.S. FDA’s mission is focused on helping to ensure that all ...
Posted by Michael Wonder on 05 Feb 2019
Risk classification of antimicrobials used in animals opens for public consultation
5 February 2019 - EMA has published today for public consultation its updated scientific advice on the categorisation of antimicrobials. ...
Posted by Michael Wonder on 24 Jan 2019
FDA statement from Commissioner announcing efforts to improve the quality of the information used to assess the effectiveness of REMS programs in supporting the safe use of medications
24 January 2019 - In making decisions about whether the benefits of a drug outweighs its risks, there are many ...
Posted by Michael Wonder on 17 Jan 2019
FDA issues letter about paclitaxel coated balloons and eluting stents
17 January 2019 - Today the FDA issued a letter to health care providers about a recent publication in the Journal ...
Posted by Michael Wonder on 15 Jan 2019
Health Canada restricts Allergan's Esmya
15 January 2019 - Health Canada has placed restrictions on Allergan's uterine fibroid treatment Esmya, after discovering a possible link ...
Posted by Michael Wonder on 09 Jan 2019
The future of FDA's electronic safety surveillance
9 January 2019 - The U.S. FDA is an information-driven agency that requires robust data to make regulatory decisions. ...
Posted by Michael Wonder on 08 Jan 2019
CDER’s work to ensure drug safety is an ongoing top priority
8 January 2019 - Yesterday, I reflected on the FDA’s Center for Drug Evaluation and Research’s wide array of new ...
Posted by Michael Wonder on 26 Nov 2018
Statement from FDA Commissioner and Director of the Center for Devices and Radiological Health on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices
26 November 2018 - Forty-two years ago, Congress passed the law establishing the framework for evaluating the safety and effectiveness of ...
Posted by Michael Wonder on 25 Nov 2018
Database tracks faulty medical devices across the globe
26 November 2018 - Patients across the world now have access to facts about faulty or dangerous medical devices — ...
Posted by Michael Wonder on 25 Nov 2018
Dangerous medical devices let through by loopholes and lax regulation
26 November 2018 - The New Orleans sales conference of medical-device maker DePuy Orthopaedics Inc. was rocking. The sound system ...
Posted by Michael Wonder on 12 Nov 2018
Oversight gap at private infusion clinics poses health risk, Ontario documents say
12 November 2018 - The lack of formal oversight at private clinics where medications are administered intravenously could pose risks ...