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 government has announced a new initiative aimed at halving the time it takes to switch a prescription-only medicine (POM) to over-the-counter (OTC) status. The government has announced a new ...

The US Food and Drug Administration (FDA) has finalized a guidance on how to conduct formal dispute resolutions (FDR) and administrative hearings to resolve scientific and/or medical disputes with ...