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"Soundness" of FDA's product approval process

Executive Summary

D.C. law firm Shaw, Pittman, Potts & Trowbridge to serve as an outside "integrity" advisor to FDA. In June, FDA hired Kutak, Rock & Campbell to advise the agency on safeguarding confidential information, particularly information of interest to the financial community ("The Pink Sheet" June 17, T&G-10). Shaw, Pittman will assess two additional areas, according to a July 10 contract: "the accuracy and completeness of data supplied by regulated parties to FDA and the objectivity and soundness of FDA's decision-making process" for product approvals and other regulatory decisions.

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