Will be issued "imminently," FDA Senior Advisor for Management and Systems Mary Jo Veverka told Jan. 13 Food & Drug Law Institute seminar in Washington. Veverka explained that the statement was previously "tabled" in order to revise the wording "to more accurately reflect how we are moving to leverage our resources." FDA has been at work on the statement for nearly two years in response to the Edwards Committee's 1991 report.
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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 budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
