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 ...

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 ...

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 ...

Drugmakers are urging the FDA to reassess the regulatory process of switching medications from prescription to over-the-counter, a rigorous procedure that must demonstrate a patient no longer needs a ...