Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—NOTICES: Obesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Comments, (May 7, 2026)
By WK Editorial Staff
The 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. (Notice, 91 Fed. Reg. 23424 (May 1, 2026)).
Dates. Submit either electronic or written comments by June 30, 2026.
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