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CBER 101 - Overview of the IND Process

CBER 101 - Overview of the IND Process

ccrod.cancer.gov

Pre-IND Meetings (21 CFR 312.82) Request must be submitted in writing (fax is fine) and should include: Description of product Description of clinical indication and approach Identification of purpose, objectives, and draft of specific questions Suggested dates and times for meeting Pre-IND meetings are scheduled within 60 days from

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