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FDA AD POLICY "UNDERMINES" EFFICACY STANDARD, "INHIBITS" SUPPLEMENTAL APPLICATIONS, EX-FDAer SAYS; SEPARATE STANDARD FOR AD DATA PROPOSED

This article was originally published in The Gray Sheet

Executive Summary

FDA's policy on product advertising "undermines" the efficacy standard by preventing the dissemination of "information on data quality" and forcing the creation of an "underground" system of data dissemination, former agency staffer Jur Strobos, MD, now with the D.C. firm Greenberg, Traurig, states in a policy paper to be released at the Food & Drug Law Institute's educational conference in Washington, D.C. on Dec. 12-13.

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