In the coming months, new pre-approval inspection compliance guidelines will be implemented at CDER. For the most part, the undertaking is designed to refine the categories that would prompt a pre-approval investigation request and make them more "risk-based," in keeping with FDA's cGMPs for the 21st Century Initiative (1"The Pink Sheet," Aug. 27, 2007, p. 27). The revisions also are supposed to clarify the role of the various offices in the process...
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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 recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.
