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Advisory Committees

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  This provision was repealed, effective October 1, 2007, by the FDA.

Joint meeting of Pulmonary-Allergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee, and the Pediatric Advisory Committees

December 10-11, 2008

Fernando Martinez, M.D.

• 18 U.S.C. 208 & 712 waiver (pdf)
• Acknowledgement and Consent (pdf)

Page updated: November 24, 2008