September 20, 2017, Covington Alert

This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.

December 22, 2016, Covington Alert

On December 13, 2016, President Obama signed H.R. 34, the 21st Century Cures Act, which became Public Law No. 114-255 (“the Act”). Its enactment represents the culmination of a multi-year bipartisan legislative process spearheaded on the House side by Energy and Commerce Committee Chairman Fred Upton, Ranking Member Frank Pallone, and Rep. Diana DeGette and on the Senate side by Committee on Health, Education, Labor and Pensions Chairman Lamar Alexander and Ranking Member Patty Murray. The Act amends the Federal Food, Drug, and Cosmetic Act (“FDCA”) and Public Health Service Act (“PHSA”), among other laws, with the aim of accelerating the discovery, development, and delivery of new medicines and medical technologies. This alert summarizes Title III of the Act on drug and device development.