It’s high school all over again for new drug approvals.
The Food & Drug Administration is proposing the development of a pilot program to assess and communicate post-marketing experience for...
Making the Grade: Reviving the New Drug "Report Card"
The Food & Drug Administration is proposing the development of a pilot program to assess and communicate post-marketing experience for newly approved drugs and biologics. The pilot, which is part of FDA's response to the Institute of Medicine report on drug safety, is a revival of the "report card" idea from the late 1990s.
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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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