Recent developments in Congress deserve the attention of companies with over-the-counter drug products. Major legislation addressing comprehensive reform of the OTC drug monograph process, which ...

In practical effect, the CARES Act brought all ongoing, non-final OTC drug monograph proceedings to a close and made final FDA’s determination in “the most recently applicable proposal” under that ...

COLUMBUS, Ohio — A new bipartisan bill introduced Wednesday aims to expand safe access to prescription drugs across the United States. The Streamlined Market Access and Reform for Therapeutics ...

Makary said the FDA is looking at prescription drugs like nausea medications and vaginal estrogen, and hopes to make changes this year.

Over-the-counter medications for sale at a pharmacy. (Photo by: Jeffrey Greenberg/Universal Images Group via Getty Images) Food and Drug Administration Commissioner Marty Makary tweeted last week that ...

Whether it's a headache, occasional heartburn or runny nose, we all know the routine: stop by the local drugstore on the way home and pick up some over-the-counter (OTC) medicine. Twist off the top, ...

The FDA, which has been talking for years about overhauling the over-the-counter (OTC) drug approval process, is taking steps it says will allow it to approve those products, and respond to safety ...

(RTTNews) - Petros Pharmaceuticals, Inc. (PTPI) on Tuesday announced its strategic position following the FDA's recently approved final rule, "Nonprescription Drug Product with an Additional Condition ...