Remove 2023 Remove Biosimilars Remove Pharmacokinetics Remove Pharmacy
article thumbnail

Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

Agency IQ

In total, since August 2023, there have been 34 new guidances added to the agenda, 58 that have been carried over to the new calendar year, and 28 which were removed (most—but not all—of which were published since the last guidance agenda update). This week, CDER published its guidance agenda for 2024.

article thumbnail

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

CDRH FY2024 Guidance Agenda Device software Select Updates for the 506J Guidance: Voluntary Notifications of Discontinuance or Interruption of Device Manufacture CDRH Draft 12/29/2023; overdue FDA must issue final guidance within one year after the close of comments for the draft guidance. New on CDRH’s guidance agenda. Priority A List.

FDA 40