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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 This provision was repealed, effective October 1, 2007, by the FDA.
Ronald Bukowski, M.D.
- 18 U.S.C. 208(b)(3) Waiver for the September 19, 2017 Meeting of the Oncologic Drugs Advisory Committee (Bukowski)
- Disclosure Document for the September 19, 2017 Meeting of the Oncologic Drugs Advisory Committee (Bukowski)