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OTC Labeling Adopted By FDA In Forced Switch Would Violate Regs Comments Say

This article was originally published in The Tan Sheet

Executive Summary

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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Rx Label Use Permissible Even If FDA Finds Drug Is Safe OTC – Attorney

A drug sponsor may create and use alternative labeling saying it requires prescription distribution for a medicine even if FDA has determined the drug does not need to be limited to the Rx arena, according to attorney Andrew Krulwich of the Washington, D.C.-based law firm Wiley, Rein & Fielding

Rx Label Use Permissible Even If FDA Finds Drug Is Safe OTC – Attorney

A drug sponsor may create and use alternative labeling saying it requires prescription distribution for a medicine even if FDA has determined the drug does not need to be limited to the Rx arena, according to attorney Andrew Krulwich of the Washington, D.C.-based law firm Wiley, Rein & Fielding

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