Agency analysis provides rare portrait of 'complete response' letters while adding to the case for increased transparency.
Sponsors will have a harder time minimizing "complete response" letters in press releases in the wake of an FDA study showing that companies rarely disclose the full reasons that the agency decided against approval – reasons that are likely to be multiple and substantive.
The analysis by the head of FDA's Office of Policy and Planning, Associate Commissioner for Public Health Strategy and Analysis...
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.’
While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
