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Henney round two

This article was originally published in The Rose Sheet

Executive Summary

FDA Commissioner-nominee Jane Henney, MD, said she would be "committed" to meeting the May 1999 deadline for the OTC sunscreen monograph set by the FDA Modernization Act in response to Sen. Tom Harkin's (D-Iowa) follow-up questions to her Senate Labor & Human Resources confirmation hearing Sept. 2. Henney also noted the advance notice of proposed rulemaking published October 1996 on foreign marketing data's material extent/material time should be completed promptly, adding she is "willing to explore mechanisms to streamline [the data] review." Replying to Sen. Dan Coats' (R-Ind.) question on FDAMA implementation, Henney said she would ensure that FDA "has an extremely open process and that the agency actively solicits industry and public input as part of the issuance of guidance documents and regulations." Henney also clarified that "enhancing FDA's science base" means "recruiting and retaining the highest quality scientific talent available." Henney's nomination is scheduled to be taken up again Sept. 23
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