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U.S. Department of Health and Human Services

Advisory Committees

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Waivers for Conflicts of Interest for the October 27, 2009 Meeting of the Anti-Infective Drugs Advisory Committee

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  This provision was repealed, effective October 1, 2007, by the FDA.

Paul Ambrose, Pharm.D.

• 18 U.S.C. 208 waiver (pdf)

• Disclosure Document (pdf)