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Research and Development Update. Jay B. Winchester 20-22 MAY 2009 USUHS. Rogue IRB. Second IRB review? Title 32 CFR 219.112: “. . .may not approve. . .if it has not been approved. . . Title 21 CFR 56.109,.112, and .113. & FDA Information Sheet # 26.
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Research and Development Update Jay B. Winchester 20-22 MAY 2009 USUHS Office of the Staff Judge Advocate, MRMC & Fort Detrick
Rogue IRB • Second IRB review? • Title 32 CFR 219.112: “. . .may not approve. . .if it has not been approved. . . • Title 21 CFR 56.109,.112, and .113. & FDA Information Sheet # 26. Office of the Staff Judge Advocate, MRMC & Fort Detrick
Congressionally Directed Funding Managed By USAMRMC PTSD, TBI, etc. Earmark—E.O. 13,457 (still good) PRMRP Office of the Staff Judge Advocate, MRMC & Fort Detrick
Congressionally Directed Funding Managed By USAMRMC USAMRAA PAN 09-02 Clinic/VA Center participation No Grant and CRADA together Solution: Cooperative Agreement Office of the Staff Judge Advocate, MRMC & Fort Detrick
FDA Vouchers for Tropical DiseasesTitle 21 USC 360n US has IP in tropical diseases(tp) Sponsor who gets approval for a tp product receives priority review voucher Voucher can be used or sold for any product review Office of the Staff Judge Advocate, MRMC & Fort Detrick
