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Focus on Regulation

Tag Archives: DC Circuit

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

Court of Appeals Rejects Challenge to Gainful Employment Rule

On March 8, a the three-judge panel of the United States Court of Appeals for the District of Columbia Circuit affirmed a lower court’s decision rejecting a challenge to the U.S. Department of Education’s “gainful employment” regulations. The regulations, which took effect July 1, 2015 (with the exception of certain disclosure requirements that will take effect

D.C. Circuit Issues Landmark Ruling for Stem Cell Therapies

The D.C. Circuit has issued a ruling that will shape the future development of stem cell therapy in the United States.  Through its February 4 decision, the court has broadly upheld FDA’s authority to regulate stem cell therapies as drugs.  Thus, any sense that the development of such therapies may be exempt from the pre-market approval