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Comment Period Regulatory Agencies Federal Food Drug and Cosmetic Act (FFDCA)

Morgan Lewis - As Prescribed

A Clearer Path from FDA for ‘Minor Changes’ to Solid Oral Dosage Forms for OTC Monograph Drugs

Recent FDA actions offer long-awaited clarity on what constitutes a ‘minor change’ to solid oral OTC dosage forms, providing manufacturers with a clearer pathway for certain modifications while maintaining a measured,...more

Bergeson & Campbell, P.C.

FDA Extends Comment Period on Method for Ranking Chemicals in Food for Post-Market Assessments

The U.S. Food and Drug Administration (FDA) announced on July 14, 2025, that it is extending the public comment period on its proposed method for ranking chemicals in the food supply by 30 days, to August 18, 2025. As...more

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