Former Metabolife President Michael Ellis is sentenced to six months in prison and ordered to pay a $20,000 fine after pleading guilty to making false statements to federal regulators, according to a judgment filed June 10 in the U.S. District Court for the Southern District of California in San Diego. Ellis told FDA in 1998 that his company had never received any consumer complaints related to its ephedra-containing Metabolife 365. The weight-control supplement firm later released 13,000 patient complaints during a criminal investigation by the Department of Justice (1"The Tan Sheet" Aug. 19, 2002, p. 3)...
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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 says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.
The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.
