Remove 2026 Remove Clinical Pharmacology Remove Licensing Remove Marketing
article thumbnail

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

Agency IQ

Priority A List. CDRH FY2024 Guidance Agenda Device software Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers CDRH Final By 10/1/24 Priority B List CDRH FY2024 Guidance Agenda Post-approval reporting 3D Printing Medical Devices at the Point of Care CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority B List.

FDA 40
article thumbnail

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

Proposed Rule Pediatric Study Plan Requirements for New Drug and Biologics License Applications October 2024 FDA is proposing to amend its existing regulations and add new regulations pertaining to submission of required initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). and the E.C.