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111. FDA Exemptions from Requirements for IND (§312.2)

The clinical investigation of a drug product that is lawfully marketed in the United States may be exempt from the requirements for an IND if all of the following conditions are true:

  • The investigation is not intended to be reported to FDA in support of a new indication for use or to support any other significant change in the labeling for the drug.
  • The investigation is not intended to support a significant change in the advertising for the product.
  • The investigation does not involve a route of administration or dosage level, use in a subject population, or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product.
  • The research is conducted in compliance with the requirements for IRB review and informed consent (§56 and 50, respectively).
  • The investigation is conducted in compliance with the requirements concerning the promotion and sale of drugs (§312.7).
  • The investigation does not intend to invoke §50.24 for the exception from informed consent requirements for emergency research.

Two other situations allow clinical investigations to be exempt from IND requirements:

  1. The clinical investigation is for an in vitro diagnostic test that

·        involves one or more of these biological products

o   Blood grouping serum,

o   Reagent red blood cells, or

o   Anti-human globulin;

·        is intended for use in a diagnostic procedure that confirms the diagnosis made by another, medically established, diagnostic product or procedure; and

·        the diagnostic test is shipped in compliance with §312.160.

  1. The clinical investigation involves use of a placebo and the investigation does not otherwise require submission of an IND.

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