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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.
February 1, 2017, 21st Century Cures Act Webinar Series
January 18, 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 ...