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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 6, 2009 Meeting of the Oncologic 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  This provision was repealed, effective October 1, 2007, by the FDA.

Oncologic Drugs Advisory Committee Meeting

October 6, 2009

Michael P. Link, M.D.

• 18 U.S.C. 208 waiver (pdf)

• Disclosure Document (pdf)