Regulatory briefings don't always just affect a single product; they can also be convened to discuss the regulatory parameters for a entire product class. One such briefing will be held in early 2009 to discuss the clinical trial design of NSAID/PPI combination products. Pozen is just one sponsor that will be affected by the outcome.
FDA is considering changes to the approval process for NSAID and proton pump inhibitor combination products that may result in the agency prohibiting the use of endoscopic gastric ulcer reduction to support a gastroprotective marketing claim.
That decision would raise the approval bar for a category of drugs that has recently become popular with certain companies:...
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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.’
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