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Pharmaceutical Industry › Administrative Orders

Morgan Lewis - As Prescribed

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

Morgan Lewis - As Prescribed on

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

Morgan Lewis - As Prescribed

Monograph Soup: The ABCs & XYZs for OTCs on Formal Meetings with FDA

Morgan Lewis - As Prescribed on

The US Food and Drug Administration (FDA) on February 1 issued a draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs” (Meeting Guidance), that specifies the procedures and principles...more

Nelson Mullins Riley & Scarborough LLP

Ushering in a New Era of OTC Drug Regulation, FDA Posts First Batch of “Deemed” Final Administrative Orders

Nelson Mullins Riley & Scarborough LLP on

On September 21, 2021, the U.S. Food and Drug Administration (“FDA” or the “Agency”) announced the posting of the first batch of final administrative orders for over-the-counter (“OTC”) drug monographs. The move marks a new...more

Arnall Golden Gregory LLP

OTC Monograph Reform – Takeaways from FDA’s Webinar on Expedited Administrative Orders

Arnall Golden Gregory LLP on

On January 27, 2021, the Food and Drug Administration held its second webinar since the enactment of the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) in March 2020, to further discuss over-the-counter...more

Mintz - Health Care Viewpoints

OTC Monograph Reform: Key Takeaways and What Industry Can Expect

Mintz - Health Care Viewpoints on

On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which in part describes reforms to modernize the regulatory framework for over-the-counter (OTC) monograph...more

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