Blend uniformity guidance withdrawn May 6 due to "scientific issues relating to the scope of the guidance and methodology for blend uniformity analysis in general," FDA said. Product Quality Research Institute's stratified sampling approach was endorsed by FDA's Pharmaceutical Science Advisory Committee (1"The Pink Sheet" May 13, p. 25). FDA will issue a revised guidance following evaluation of the PQRI proposal. Companies must still "monitor and validate the performance of processes that could be responsible for [product] variability, including adequacy of mixing," FDA noted. The guidance, "ANDAs: Blend Uniformity Analysis," was issued in 1999...
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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.
