The share of drug reviews funded by industry fees has climbed steadily over two decades, and is going to jump again once generic drug and biosimilar fees become reality. It may be time to move to an all user fee model for drug reviews.
Is the Food & Drug Administration on a path towards 100% user fee funding? It just might be, says Alan Goldhammer.
Not just FDA, actually: given the overall budget climate, Goldhammer said during the Food & Drug Law Institute annual meeting April 5, "I wouldn't be surprised to see serious efforts...
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.
