By Kate Rawson
There’s a funny thing happening at the Food & Drug Administration these days: more drugs are getting approved by the agency. According to some investors, products that perhaps wouldn’t have...
Woodcock to the Rescue: Is CDER Approving More Products?
The financial community believes in Janet Woodcock: some analysts are predicting an improving climate for drug approvals based on her return to FDA's Center for Drug Evaluation & Research. Woodcock says standards aren't changing-but she does seem to relish making the tough decisions that make some approvals possible.
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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.’
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The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
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The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.
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The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.