What criteria must be met if a study can be exempted from requiring an IND?

A study can be deemed IND Exempt if all of the following criteria are met:

  • If the study is not designed to support approval of a new indication or a change in label;
  • If the study is not intended to support a significant change in the advertising for the product;
  • If the study does not involve a route of administration, dosage level or patient population that significantly increases the risks (or decreases the acceptability of risk) associated with the use of the drug;
  • The study is conducted in compliance with the IRB and Informed Consent regulations; and
  • The study is conducted in compliance with regulations regarding promotion for investigational drugs.

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