FDA expects the Center for Drug Evaluation & Research to receive 17% more adverse reaction reports in fiscal year 2006 than it received in FY 2004
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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.’
The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.
Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.
Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.
