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This month I wanted to take a data-driven look at FDA’s treatment of citizen petitions, and specifically as a starting point how quickly the agency resolves those petitions. Make no...
Pediatric Advisory Committee Meeting Announcement
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The FDA has released for public comment a proposed draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or...
Agenda The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On December 10, 2020, the Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older. Meeting Materials FDA intends to make background material available to the public no later than 2 business days before the meeting. If FD...