Blog
RSS FeedPosted by Michael Wonder on 10 May 2017
New safety risks detected in one-third of FDA approved drugs
9 May 2017 - Almost a third of drugs cleared by the Food and Drug Administration pose safety risks that ...
Posted by Michael Wonder on 08 May 2017
Involving patients in discussions on benefits and risks of medicines
8 May 2017 - EMA publishes report on CHMP pilot project. ...
Posted by Michael Wonder on 04 May 2017
The failure of solanezumab — How the FDA saved taxpayers billions
3 May 2017 - The failure of solanezumab offers a window into the U.S. drug regulatory system, particularly in the context ...
Posted by Michael Wonder on 01 May 2017
Reform of the Orphan Drug Program - transition arrangements
1 May 2017 - The Orphan Drug Program provides an incentive for sponsors to bring medicines for a small population to ...
Posted by Michael Wonder on 29 Apr 2017
Accelerating development of scientific evidence for medical products within the existing US regulatory framework
1 May 2017 - Growing access to diverse 'real-world' data sources is enabling new approaches to close persistent evidence gaps about ...
Posted by Michael Wonder on 29 Apr 2017
The wider role of regulatory scientists
27 April 2017 - Why they must help us improve the evidence base. ...
Posted by Michael Wonder on 29 Apr 2017
EMA and heads of national competent authorities discuss consequences of Brexit
28 April 2017 - Key principles and working methodology established. ...
Posted by Michael Wonder on 27 Apr 2017
U.S. top court grapples over making copycat biologics available sooner
26 April 2017 - U.S. Supreme Court justices on Wednesday struggled over whether to speed up the time it takes ...
Posted by Michael Wonder on 26 Apr 2017
Changes to pharmaceutical extension of term application procedures the latest front in the battle for savings in Australia’s health care budget
26 April 2017 - It’s no secret that the Australian Government is struggling to manage the cost of its health ...
Posted by Michael Wonder on 25 Apr 2017
FDA takes action against fraudulent cancer products
25 April 2017 - A cancer diagnosis often provokes a sense of desperation. Unfortunately, rogue operations exploiting those fears peddle untested ...
Posted by Michael Wonder on 24 Apr 2017
Open letter from the Pharmaceutical Industry Heads of Research and EFPIA on the relocation of the European Medicines Agency
24 April 2017 - Our current system of medicines regulation offers an outstanding example of European cooperation at its finest. ...
Posted by Michael Wonder on 20 Apr 2017
France backs Lille as best choice to host EU drug agency after Brexit
20 April 2017 - France offered the northern city of Lille as a candidate to host the European Union's drug ...
Posted by Michael Wonder on 18 Apr 2017
Submissions received and TGA response: orphan drug program
18 April 2017 - The TGA would like to thank respondents who provided submissions in response to the October 2016 ...
Posted by Michael Wonder on 14 Apr 2017
Fast start for FDA drug approvals in 2017
12 April 2017 - The US FDA is poised to make a comeback from the relatively low number of new ...
Posted by Michael Wonder on 14 Apr 2017
Trump dangles Obamacare payments to force Democrats to the table
12 April 2017 - Cutting off a key subsidy program could send Obamacare’s insurance markets into a tailspin. ...