How The FDA Can Compel Post-Marketing Studies

Law360 (April 29, 2011, 5:21 PM EDT) -- The U.S. Food and Drug Administration announced in the Federal Register on April 1 the availability of a draft guidance for industry titled "Post-Marketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food, Drug and Cosmetic Act" (the draft guidance). Comments on the draft guidance may be submitted at any time....

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