Clinical Pharmacology Corner: FDA Establishes Public Docket Entitled “Obesity and Drug Dosing: Clinical Pharmacology Considerations”

https://www.govinfo.gov/content/pkg/FR-2026-05-01/pdf/2026-08521.pdf?utm_medium=email&utm_source=govdelivery FDA Establishes Public Docket Entitled “Obesity and Drug Dosing: Clinical Pharmacology Considerations” Today, the U.S. Food and Drug Administration (FDA) established a public docket entitled “Obesity and Drug Dosing: Clinical Pharmacology Considerations.” The purpose of this docket is to solicit input on incorporating the assessment of obesity’s effect 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. FDA invites interested persons to provide detailed information and comments on relevant considerations for evaluating the impact of obesity on drug pharmacokinetics, pharmacodynamics, and the need for specific dosage recommendations. Submit any comments regarding this notice to the public docket (Docket No. FDA-2026-N-3499) until June 30, 2026. Visit the Federal Register notice for additional information on how to comment.