Class III recall of 51 lots of conjugated estrogen tablets is not related to an inspection or warning letter, Wyeth-Ayerst says. The Premarin and Premphase products involved in the Oct. 16 recall were manufactured at Wyeth's Rouses Point, N.Y. and Guayma, Puerto Rico plants. Wyeth's Pearl River, N.Y. and Marietta, Penn. injectable manufacturing plants are currently operating under an FDA consent decree. (For more information on the recall, see FDA's Dec. 6 "Enforcement Report," p. 26.)
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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 group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.
Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.
The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
