2026, Clinical Pharmacology and Licensing

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2026

Clinical Pharmacology

Licensing

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

Agency IQ

FEBRUARY 15, 2024

CDER, CBER 9/30/2026 Revised or final guidance to be released 18 months after the public comment period ends PDUFA Commitment Letter Patient-Focused Drug Development FDA must issue or update guidance regarding the Agency’s collection of information from medical device facilities prior to inspection. Priority B List.

FDA

FDA Science Biosimilars Clinical Trials

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

Agency IQ

JULY 12, 2024

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).

Regulations

Regulations FDA Science Production

Drug Discovery Digest

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

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

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