Blend uniformity guidance withdrawn May 6 due to "scientific issues relating to the scope of the guidance and methodology for blend uniformity analysis in general," FDA said.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 European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
The European Medicines Agency has recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy, despite the product securing approvals in the US and other markets.
