JD Supra

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 ...
JD Supra

FDA to Publish Guidance to Improve the Rx to OTC Switch Application Process

The pressure is building for the U.S. Food and Drug Administration (FDA) to take steps to facilitate making more drugs available over-the-counter (OTC) that currently require a prescription. As part ...
Seeking Alpha

Petros Pharmaceuticals Strategically Positioned to Benefit as Technology Leader from Newly Approved FDA OTC Final Rules

NEW YORK, NY / ACCESSWIRE / January 7, 2025 / Petros Pharmaceuticals, Inc. (PTPI) ("Petros" or the "Company"), a company focused on expanding consumer access to medication through over-the-counter ...
WUNC

Birth control use is up since FDA approved over-the-counter pill

It's only been a couple of years since the FDA approved the sale of over-the-counter birth control pills available without a prescription. A new study published today in JAMA Network Open shows this ...