Advisory Committees

Waivers for Conflict 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  This provision was repealed, effective October 1, 2007, by the FDAAA.

Circulatory System Devices Panel

October 10 & 11, 2007

Edwin C. Gravereaux, M.D.

• 18 U.S.C. 208 waiver (pdf)
• 712 (c) (2) (B) waiver (pdf) (updated 10/10/2007)
• Acknowledgement of 712 (c) (2) (B) waiver (pdf) (updated 10/10/2007)

JoAnn Lindenfeld, M.D.

• 18 U.S.C. 208 waiver (pdf)
• Acknowledgement and Consent (pdf)
• 712 (c) (2) (B) waiver (pdf) (updated 10/10/2007)

David C. Naftel, Ph.D.

• 18 U.S.C. 208 waiver (pdf)
• Acknowledgement and Consent (pdf)
• 712 (c) (2) (B) waiver (pdf) (updated 10/10/2007)

John C. Somberg, M.D.

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

Judah Z. Weinberger, M.D., Ph.D.

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

Page updated: October 10, 2007