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Get Fdas Clinical Investigator Course

Nger maintained and may be outdated. FDA s Clinical Investigator Course Preparing an IND Application: CBER Breakout Session Clinical Considerations for Cell and Gene Therapy Products Rachel Witten, M.D. FDA/CBER/OCTGT/DCEPT November 9, 2011 Cosponsored by FDA s Office of Critical Path Programs (OCPP) and The Clinical Trials Transformation Initiative (CTTI) What is FDA looking for (in an IND) IND process Clinical protocol and review process Informed consent and assent Po.

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