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2 Drug /Biologic Name and Manufacturer IND EXEMPTION CRITERIA TRUE FALSE 1 a The investigation IS NOT intended to be reported to the FDA as a wellcontrolled study in support of a new indication for use. Consent 21 CFR Part 50. 24 Principal Investigator Name print Date IND/IDE Assistance Program USE ONLY IND FDA Approval Required Recommend Application for FDA IND Exempt Status IND Exempt pending final determination from IRB These preliminary recommendations are based on discussions with the...
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Columbia University Medical Center is a prestigious academic medical center located in New York City.
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Information such as financial disclosures, conflicts of interest, research funding, and relevant relationships must be reported.
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