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- Second Circuit Recognizes Significant First Amendment Protections for Off Label Promotion
Second Circuit Recognizes Significant First Amendment Protections for Off-Label Promotion
December 7, 2012, Covington E-Alert
February 9, 2018, 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 ...
D.C. District Court Rules FDA Has Inherent Authority to Rescind 510(k) Clearance in "Rare Situation"
April 26, 2013, Covington E-Alert