Six top industry insiders recently shared with "The Tan Sheet" their thoughts on the pending release of FDA's final rule on dietary supplement Good Manufacturing Practices. The participants were: Scott Bass of the law firm Sidley Austin Brown & Wood; Council for Responsible Nutrition President Annette Dickinson, PhD; Utah Natural Products Alliance Executive Director Loren Israelsen; American Herbal Products Association President Michael McGuffin; U.S. Pharmacopeia Director-Dietary Supplements David Roll, PhD; and National Nutritional Foods Association Executive Director & CEO David Seckman.
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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 new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.
Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.
If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
