In Brief: FDA reform
This article was originally published in The Tan Sheet
Executive Summary
FDA reform: CDER Division of OTC Drug Evaluation Director Debra Bowen, MD, to serve as agency contact for working groups assigned with developing implementation plans for provisions in the FDA Modernization Act pertaining to OTC labeling, completion of the sunscreen monograph and studies of mercury in nasal sprays. Contacts and mandatory deadlines for the many statutes of the act are listed in a Feb. 2 draft implementation plan. FDA created the working groups to determine whether provisions in the new act require rulemaking or are mandated ("The Tan Sheet" Jan. 19, p. 13). CFSAN Division of Programs and Enforcement Policy Director Elizabeth Campbell will head the working group on health claims and nutrient content claim petitions. The complete list of working group contacts is available at FDC Reports' home page at www.fdcreports.com...
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