Module 1 2021

When is an IND NOT required?

The clinical investigation of a marketed drug or biologic does not require submission of an IND provided all six of the following conditions are met: • It is not intended to support a new indication for user or to support any other significant change in the labeling • It is not intended to support a significant change in the advertising for the product • It does not involve a route of administration or dosage level, use in the subject population, or other factor that significantly increases the risk associated with the use of the drug product • It is conducted in compliance with the requirements for IRB review and informed consent • It is conducted in compliance with the requirements concerning the promotion and sale of drugs • It does not intent to invoke 21 CFR 50.24 (exceptions from informed consent requirement for emergency research)

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IND  Clinical Trial/Program Initiation • Types of INDs − Sponsor (Company/Corporate) IND − Investigator (Research) IND (named investigator is Sponsor) − Emergency Use IND (named patient/compassionate use, bypasses IRB) − Treatment IND (multiple patients for an indication being studied under ‘regular’ IND) − Exploratory IND (micro-dosing in Phase 0) • Initiation of Clinical Trials − Sponsor (company) may begin trials 30 days after filing IND, unless otherwise notified by FDA − Note: IRB approval required − During development, maintain ongoing communication with FDA to help guide the program (e.g., EOP 1/2 meetings)

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