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Regulatory Agencies New Guidance Pharmaceutical Industry

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

Smart & Biggar

Updated PMPRB Guidelines expected in summer 2025 and NPDUIS releases ninth edition of the Meds Entry Watch Report

Smart & Biggar on

In the Patented Medicine Prices Review Board (PMPRB)’s June 2025 NEWSletter, Acting Chairperson Anie Perrault confirms that the PMPRB plans on publishing its final Guidelines in summer 2025. This will mark the completion of...more

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