Agency IQ

SEPTEMBER 29, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

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Agency IQ

JUNE 16, 2023

to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. The rule, will also, if finalized, address communication with State boards of pharmacy. The final rule will amend the administrative destruction provisions in 21 CFR 1.94

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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Agency IQ

DECEMBER 1, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The following PDUFA dates were obtained from publicly available sources.

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