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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

Research and Development Update

Jay B. Winchester

20-22 MAY 2009

USUHS

Office of the Staff Judge Advocate, MRMC & Fort Detrick

rogue irb
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

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 usamrmc1

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 diseases title 21 usc 360n

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