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21st Century Cures Act: Key Provisions (Title III - Development)
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.
May 2020
As the legal, regulatory, and commercial implications of coronavirus COVID-19 continue to evolve, our lawyers and advisors are helping clients navigate the complex considerations that companies around the world are facing and develop plans and strategies in response. Reach out to our COVID-19 task force at COVID19@cov.com. Below is a compendium of resources ...
March 14, 2019, Covington Alert
This alert is part of a series of 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.
January 17, 2017, Covington Alert
On January 13, 2017, the U.S. Food and Drug Administration (FDA or Agency) released a discussion paper synthesizing public feedback on FDA’s 2014 draft guidance documents and outlining a possible approach to regulation of laboratory developed tests (LDTs) (Discussion Paper). This approach is intended to “advance the public discussion by providing a possible ...