The distributor of a coffee product found to contain an analogue of the erectile dysfunction drug sildenafil receives an official FDA warning letter Aug. 23, following a consumer advisory and voluntary recall in June (1"The Tan Sheet" July 5, 2010, In Brief). INZ Distributors of Brooklyn, N.Y., sells an unapproved, misbranded new drug, the agency's New York District office says. Magic Power Coffee is an adulterated food, due to the presence of an ingredient not generally recognized as safe, and improperly labeled as a dietary supplement given its representation as a conventional food/beverage, FDA says. INZ faces product seizures and possible injunction if it fails to correct the violations within 15 days, according to the letter
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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 EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.
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.
