"It appears that FDA is not taking action against [androstenedione] products because you can't decide whether it's a supplement or a drug," Sen. Orrin Hatch (R-Utah) tells FDA General Counsel Daniel Troy during an Aug. 1 Senate Judiciary committee hearing on the "Greater Access to Affordable Pharmaceuticals Act." "I'm counting on FDA moving forward on this, to protect the public health," Hatch continued, "because I think this inaction has been going on far too long." Troy promised to relay concerns to FDA Commissioner Mark McClellan, MD/PhD...
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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.
