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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 This provision was repealed, effective October 1, 2007, by the FDA.
Gastrointestinal Drugs Advisory
Committee
January 23, 2008
Joseph Cullen,
M.D.
- 18 U.S.C.
208 waiver (pdf)
- Acknowledgement
and consent (pdf)
Michael Epstein,
M.D.
- 18 U.S.C.
208 waiver (pdf)
- 712 (c)
(2) (B) waiver (pdf)
- Acknowledgement and consent (pdf)
Sean Hennessy,
Pharm.D., Ph.D.
- 18 U.S.C.
208 waiver (pdf)
- 712 (c)
(2) (B) waiver (pdf)
- Acknowledgement and consent (pdf)
Page updated:
January 8, 2008
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