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Obesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Comments

Comment period closed: closed 109 days ago (Jun 30, 2026).

Read on FederalRegister.gov · Official PDF · Docket on Regulations.gov · Add to calendar (.ics)

Summary (from the Federal Register abstract)

The Food and Drug Administration (FDA) is establishing a public docket entitled "Obesity and Drug Dosing: Clinical Pharmacology Considerations." The Agency is soliciting input from interested persons on assessing the effect of obesity on drug pharmacokinetics and pharmacodynamics during drug (including biological product) development. These assessments could potentially inform whether obesity impacts the safety and effectiveness of the drug and dosing recommendations for obese patients.

Document type: Notice
Federal Register document number: 2026-08521
Published: May 1, 2026
Action: Notice; establishment of a public docket; request for comments.
Docket: FDA-2026-N-3499
Comments posted on Regulations.gov (at last check): 16
DATES section (from the document): Submit either electronic or written comments by June 30, 2026.
Topics (auto-tagged): Other FDA topics

Source: Federal Register API, document 2026-08521. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.