Pediatric Priority Review Voucher Designations Near 30; How Many Can Beat Sunset Date?
FDA has designated 29 products under the rare pediatric disease incentive program – all with the potential to win a voucher for a priority review of another product. That means two dozen products are racing the clock ahead of the Sept. 30 sunset date for the program.
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Transparency On COVID Vaccine Clinical Holds Needed, Sharfstein Says; US FDA Advisory Cmtes Offer Venue
Former acting Commissioner Josh Sharfstein argues that while agency officials have done a commendable job in overall communication on COVID vaccine development, more information is needed on the clinical holds.
As US FDA recovers from aducanumab and looks towards an advisory committee on Pfizer’s COVID vaccine, it’s worth reflecting on how Office of Vaccine Research & Review Director Marion Gruber created positive turning points for the agency during a general discussion of vaccine approval standards at the VRBPAC.