Rx-TO-OTC SWITCH NDAs: ONE CLINICAL TRIAL/ONE ACTUAL-USE STUDY SUGGESTED by FDA consultant Bernard Schachtel, MD, as a possible alternative to the requirement of two adequate and well-controlled clinical trials for Rx-to-OTC switch applications. Speaking at the Nonprescription Drug Manufacturers Association's annual R&D conference on Sept. 13 in Washington, D.C., Schachtel discussed "innovative approaches" to six issues relevant to OTC clinical trials.
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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.’
There are now three draft versions of the legislative text that will overhaul the framework governing pharmaceuticals in the EU. Lawyers explain how the approaches proposed by the European Commission, European Parliament and Council of the EU differ and highlight implications for industry.
England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.
Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
