JD Supra

FDA Releases New Enforcement Policy for OTC Sunscreen Drug Products Marketed Without an Approved Application

In May 2018, the Food & Drug Administration (FDA) released a new enforcement policy for over-the-counter (OTC) sunscreen drug products marketed without an approved application. While sunscreens have ...
JD Supra

FDA to Publish Guidance to Improve the Rx to OTC Switch Application Process

The pressure is building for the U.S. Food and Drug Administration (FDA) to take steps to facilitate making more drugs available over-the-counter (OTC) that currently require a prescription. As part ...