Pink Sheet Podcast: US COVID-19 Booster Plan, Restated PDUFA Fees, More FDA Adcomm Power?
Pink Sheet reporter explains the increased pressure on the FDA now that a coronavirus vaccine booster plan is in place, the surprising results of a survey of agency advisory committee members, and the recalculation of FY 2022 PDUFA fees.
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Despite acknowledging that fully in-person meetings overall are better, survey respondents said they still want the flexibility that virtual attendance offers.
Program growth beyond supplements will be determined after the agency gains experience with STAR program, PhRMA executive tells the Pink Sheet.
Industry feels that sufficient program management tools are in place, but a PDUFA VII negotiator says they need more time to mature.