...show a resurgence in recalls related to application integrity issues. Potency problems continue to be the source of a high percentage of recalls. Overall, the number and types of drug product recalls reported in 1997 are in line with the 1996 tally. Labeling/packaging recalls are an exception, more than doubling from the prior year. Comments on a proposed cGMP rule modifying the cut labeling provisions are under review at FDA. Recalls of injectables also spike in 1997. FDA considers four drug recalls involving various dosage forms and one therapeutic biological recall dangerous enough to warrant a Class I rating. [A nine-page tabulation of recalls listed in FDA "Enforcement Reports" during 1997 is included.]
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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.’
Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.
Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.
The Pediatric Advisory Committee will review postmarketing safety for three vaccines and the oncologic drugs panel will consider the return of GSK’s belantamab mafodotin. An FDA notice about a 30 July meeting on Capricor’s deramiocel for Duchenne muscular dystrophy was withdrawn.
