FDA Regulatory Framework For Ephedra Ban Expected To Get Court Review
FDA's regulatory framework for removing dangerous dietary supplements from the market under the Dietary Supplement Health & Education Act's "unreasonable risk" standard will be issued shortly by the agency
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The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.
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Sector-specific tariffs, including on pharmaceuticals, could be announced as early as this week.
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Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.