Post-Marketing Study Deadlines Urged As House Tackles FDA Safety Effort
• By Cathy Dombrowski
FDA should revisit the post-marketing studies that firms have outstanding, eliminate many of them, and set firm deadlines for the remaining trials, academics suggested at a March 22 hearing by the House Energy and Commerce/Oversight and Investigations Subcommittee
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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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In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.
A “basket approach” to phasing out animal testing could help identify areas where “moonshot” research is required to implement new approach methodologies, according to EU industry federation EFPIA.