Waivers for Conflicts of Interest for the November 5, 2010 Meeting of the Gastrointestinal 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 This provision was repealed, effective October 1, 2007, by the FDA.
Gastrointestinal Drugs Advisory Committee Meeting
November 5, 2010
Susan Orenstein, M.D.