Waiver for Conflicts of Interest for the June 28-29, 2016 Meeting of the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee (PedsODAC)
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Disclaimer
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 This provision was repealed, effective October 1, 2007, by the FDA.
Steven Dubois, M.D.
- Steven Dubois - 18 U.S.C. 208(b)(3) Waiver for the June 28-29, 2016 Meeting of the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee
- Steven Dubois - Disclosure Document for the June 28-29, 2016 Meeting of the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee
Ira Dunkel, M.D.
- Ira Dunkel - 18 U.S.C. 208(b)(3) Waiver for the June 28-29, 2016 Meeting of the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee (PDF-241KB)
- Ira Dunkel - Disclosure Document for the June 28-29, 2016 Meeting of the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee
Kathleen Neville, M.D.
- Kathleen Neville - 18 U.S.C. 208(b)(3) Waiver for the June 28-29, 2016 Meeting of the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee
- Kathleen Neville - Disclosure Document for the June 28-29, 2016 Meeting of the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee