Federal Register #FDA2026N3499

FDA Request for Comments on Obesity and Drug Dosing Clinical Pharmacology Considerations

The Food and Drug Administration (FDA) is requesting public input on clinical pharmacology considerations related to obesity and drug dosing. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Center for Drug Evaluation and Research - OEMs and Vendors: - No OEMs or vendors are mentioned; this is a request for information, not a product or service procurement - Products/Services Requested: - No products or services are being requested - The FDA seeks detailed comments and supporting data on: - The impact of obesity on drug pharmacokinetics and pharmacodynamics - Adequacy of body mass index as a measure - Drug-specific characteristics and study design considerations for clinical trials - Unique/Notable Requirements: - Respondents should provide supporting data and rationale for their suggestions - Comments may be submitted electronically or in writing - Place of Performance/Delivery: - FDA offices in Rockville and Silver Spring, Maryland

Description

The Food and Drug Administration (FDA) is establishing a public docket to solicit input on assessing the effect of obesity on drug pharmacokinetics and pharmacodynamics during drug development, including biological products. The goal is to understand how obesity impacts drug safety, effectiveness, and dosing recommendations for obese patients. The FDA invites detailed information and comments on evaluating obesity's impact and appropriate dosing strategies. Comments are due by June 30, 2026.

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