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U.S. Department of Health and Human Services

Advisory Committees

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May 14, 2009: Meeting of the Cellular, Tissue and Gene Therapies Advisory Committee Meeting Waivers for Conflicts of Interest

The Food and Drug Administration Amendments Act of 2007 (FDAAA), enacted on September 27, 2007, added a new provision regarding financial conflicts of interest, § 712 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), effective October 1, 2007. Accordingly, for advisory committee meetings after October 1, 2007, FDA is granting waivers under 18 U.S.C. § 208 and § 712 of the FD&C Act, where applicable, when the relevant waiver standards in these statutes are met.

Waivers under 21 U.S.C. § 355(n)(4) were issued before October 1, 2007.  This provision was repealed, effective October 1, 2007, by the FDA.

Cellular, Tissue and Gene Therapies Advisory Committee

May 14, 2009

Richard N. Pierson, III, M.D.