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Home : Membership : New Investigator Center of Educational Resources (NICER) : NICER: FDA & RAC Guidance
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NICER: FDA & RAC Guidance
Suggest an FDA or RAC resource
FDA gene therapy IND information website
Guidance from FDA about RCR testing:
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Guidance for Industry: Gene Therapy Clinical Trials - Observing Subjects for Delayed Adverse Events
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Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors