Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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Biosimilar Advisory Committees Getting Smoother, Even As Worries Stay The Same
US FDA advisors overwhelming endorse Hospira's biosimilar referencing Amgen's Epogen, but still wanted broader immunogenicity data and postmarketing surveillance.
MoCRA’s Adulteration Ambiguity And FDA’s New Cosmetic Recall Authority: Attorney Weighs In
The US FDA should use guidance or rulemaking to clarify MoCRA provisions related to adulteration, Amin Wasserman Gurnani attorney Angela Diesch suggested at the Independent Beauty Association’s Cosmetics Convergence Spring Symposium. Attendees also sought her take on whether the agency’s new recall authority is likely to spell an increase in cosmetic product recalls.
Medtronic Launches Remote Live-Stream Surgery, New AI Capabilities
Medtronic will launch a new feature that allows for live streaming of surgical procedures in more than 20 countries and the addition of 14 AI-driven algorithms to enhance surgical workflow.