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In Brief: FDA reform implementation

This article was originally published in The Rose Sheet

Executive Summary

FDA reform implementation: Division of OTC Drug Products Director Debra Bowen, MD, named agency contact for the FDA working group charged with completing the sunscreen final monograph. The final rule must be completed by May 21, 1999 as mandated by the FDA Modernization Act. Bowen is also the contact on the OTC national uniformity working group for OTC drug issues, in conjunction with Office of Cosmetics & Colors Director John Bailey, PhD, who heads the four-member uniformity group for cosmetics ("The Rose Sheet" Jan. 26, p. 2). The working groups have been organized to develop implementation plans for all provisions of the FDA reform act. Contacts and mandatory deadlines for executing statutes are listed in a Feb. 2 FDA draft implementation plan. The complete list of the agency task groups is available on F-D-C Reports' Internet home page at www.fdcreports.com. Click on "FDA Reform Bill" and follow the path to "FDAMA Implementation Contacts"...
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