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 ...

President Trump’s recent executive order on pharmaceuticals includes a section on facilitating switches of prescription-only drugs to over-the-counter status. Attempts to address the issue of ...

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 ...

Switching a prescription drug can make economic senseAfter a nearly two-year pause, six drugs have been approved to make the switch from prescription to over-the-counter (OTC) status in the last 12 ...