FDA-Initiated OTC Switches Could Be Based On Foreign Data – McClellan
This article was originally published in The Tan Sheet
FDA may rely on a drug's foreign OTC marketing experience to determine whether an Rx product should be switched OTC in the U.S. without sponsor consent, Commissioner Mark McClellan, MD/PhD, said at a Manhattan Institute roundtable discussion for buyside analysts May 16
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FDA could not adopt a drug's approved OTC label from another country as acceptable U.S. OTC labeling without violating its own regulations, according to the American Association of Physicians & Surgeons and Competitive Enterprise Institute
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