Warning! FDA Is Flexing Its PMR Enforcement Muscle

Law360, New York (April 20, 2012, 1:12 PM EDT) -- A recent U.S. Food and Drug Administration (FDA) warning letter suggests that the agency will not hesitate, when necessary, to exercise its power to enforce postmarketing requirements (PMRs) for approved drug products.[1]

The warning letter states that the recipient company failed to submit a required study protocol and final study report, pursuant to the company’s PMRs, and, therefore, the drug products are misbranded under the Federal Food, Drug and Cosmetic Act (FDCA).[2]

This article will focus on the FDA’s general concerns and its enforcement approach rather...
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