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Focus on Regulation

Tag Archives: NDAs

12 Years Later: Court Prohibits Marketing of Prescription Versions of OTC Drug

In a big win for the Food and Drug Administration (FDA), the D.C. Circuit of the United States Court of Appeals reinforced FDA’s position on what constitutes a “meaningful difference” between prescription and over-the-counter (OTC) versions of a drug product.  Under FDA’s longstanding interpretation, section 503(b) of the Food, Drug, and Cosmetic Act (FDCA) “does

President signs The Food and Drug Administration Safety and Innovation Act: Summary of certain key provisions

President Obama recently signed into law The Food and Drug Administration Safety and Innovation Act (FDASIA). FDASIA will reauthorize for another five years the Prescription Drug User Fee Act (PDUFA V) and the various related user fee agreements between the drug and device industries and FDA. FDASIA includes provisions related to drugs, devices, generic drugs,