How The FDA Can Compel Post-Marketing Studies

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PM EDT) -- The U.S. Food and Drug Administration announced in the Federal Register on April 1 the availability of a draft guidance for industry titled “Post-Marketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food, Drug and Cosmetic Act” (the draft guidance). Comments on the draft guidance may be submitted at any time.

The draft guidance represents another prong of the expansion of the FDA’s authority under the 2007 amendments to the Federal Food, Drug and Cosmetic Act (the FD&C Act), and any applicant...
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