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Regenerative Medicine and Combination Products
February 1, 2017, 21st Century Cures Act Webinar Series
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.
October 13, 2016, Covington Alert
On September 21, 2016, the National Institutes of Health (NIH) published its final rule, Clinical Trials Registration and Results Information Submission, 42 C.F.R. Part 11. Under Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA), “responsible parties” for specified clinical trials of FDA-regulated drug and device products must submit clinical trial registration information to a publicly available website at www.ClinicalTrials.gov. Responsible parties for specified clinical trials of FDA-approved drug and device products are required to submit clinical trial results information and certain adverse events information to the database as well.