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FDA Moves Toward Easing Restrictions on Compounded Peptides
The Trump administration is advancing an interim plan to allow compounding pharmacies to produce certain unapproved peptides despite FDA scientists' findings that available evidence is insufficient to establish their safety and effectiveness. HHS 10/15 submitted an "interim access policy" for peptides to the White House Office
Opinion Urges FDA to Eliminate Unnecessary Biosimilar Clinical Trials
FDA should eliminate “redundant biosimilar trials when rigorous scientific evidence already establishes similarity,” a 10/16 Newsweek opinion piece by Sarfaraz K. Niazi says. The commentary argues that advances in analytical testing now allow manufacturers to demonstrate that proposed biosimilars are highly similar to reference biologics without necessarily conducting additional
Foreign Clinical Trial Data and Raising Risks for Sponsors
FDA is ramping up oversight of clinical trials conducted outside the U.S., placing greater emphasis on data integrity, GMP compliance and the applicability of foreign study results to American patients, according to an analysis by attorneys at Foley Hoag LLP. In a 10/16 client alert, attorneys Matthew Piscitelli
Early Alert: Transcatheter Mitral Valve Delivery System
CDRH has issued an early alert after learning that Edwards Lifesciences notifed customers recommending certain delivery systems used for SAPIEN M3 transcatheter mitral valve replacement be removed from where they are used or sold. Affected devices: * Commander M delivery systems (for SAPIEN M3 Transcatheter Mitral Valve Replacement System); Lots: 67718561,