The new group of Drug Safety & Risk Management Advisory Committee members comprises a lot of familiar faces. FDA has made use of its extensive outside academic connections, research grants and post-graduate training programs to bring in eight members for the Classes of 2013 and 2014. Most of them have been getting extensive on-the-job training with the advisory committee already.
By Cole Werble
The Drug Safety & Risk Management Advisory Committee is arguably the Food & Drug Administration's most important drug committee. By...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.
The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.
In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.
