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Executive Summary

GENERIC MANUFACTURER TASK FORCE SUPPORTS "IN VITRO" TESTING to determine the bioequivalence of generic topical drug products. "The Pink Sheet," in a story on the Topical Task Force's Jan. 22 petition to FDA (Jan. 29, T&G-4), highlighted the group's position that it would support use of a hybrid ANDA/NDA process in lieu of a full NDA requirement by FDA. "The Pink Sheet" also noted, albeit further down in the story, that the "first choice" of the task force is "valid in vitro methodologies." In a Feb. 1 letter to "The Pink Sheet," Gary Yingling (D.C. law firm of McKenna, Conner & Cuneo), counsel for the task force, said the group "strongly" believes that "The Pink Sheet" article "unfairly characterizes the contents" of the group's petition to FDA. "Although the Task Force advocated a number of alternative positions within these comments, our primary emphasis was, and remains, that in vitro studies are sufficient to establish the bioequivalence of generic topical drug products," the letter states. "The Task Force only supports the position of a hybrid NDA/ANDA filing if the agency fails to recognize the validity of in vitro methodologies to demonstrate bioequivalence for these topical products. Indeed, we deliberately placed the 'hybrid' discussion in the latter part of our submission so as to avoid the misconception "The Pink Sheet" article reflects." The petition was submitted to FDA by Yingling on behalf of the Topical Task Force. The group is comprised of officials from Altana, Clay-Park Labs, Lemmon, NMC Labs, Taro Pharmaceuticals, and Thames Pharmacal.

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