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 ...

A complete overhaul to the over-the-counter (OTC) drug system quietly rode its way into law with the Coronavirus Aid, Relief, and Economic Security Act or the CARES Act (H.R. 748), along with several ...

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 ...

Over-the-counter (OTC) medications can be purchased without a prescription and are generally used for minor ailments, while prescription drugs require a doctor’s order and typically treat more serious ...

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 ...

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 ...