Who Must Apply for an IND?

Who Must Apply for an IND?

An Investigational New Drug (IND) is issued by the FDA to facilitate moving forward with more advanced testing on that drug. At this stage, the potential new drug is still a long way from final FDA approval for marketing, but it has shown promise in lab tests.

To begin clinical investigations, an IND is required because the FDA does not allow any human testing without approval. Un-approved, unlabeled drugs also cannot be transported across state lines without an IND designation. This restriction makes broader testing of a new drug impossible without FDA approval. An IND is exempt from this transportation restriction.

The manufacturer of a new drug or its sponsor must apply for an IND unless their clinical investigation is exempt. The three most common exemptions are:

Marketed drug products. Clinical trials conducted on drugs that are already approved by the FDA and on the market can be exempt from IND. The clinical trials must be conducted in compliance with FDA rules for such investigations and cannot be used to change the uses or route of administration for the drug.

Bioavailability studies. Studies can be conducted on an unapproved drug that closely resembles an FDA approved drug without an IND. This exemption was intended to facilitate generic drug development but does not have to be used for that purpose. The drug being studied must not contain any new chemicals or be cytotoxic.

Radioactive drugs. Human testing of radioactive drugs, either approved or un-approved, can be exempt from IND because the substances involved are commonly recognized as safe. The exempt tests must be for research purposes only and not intended for diagnostic or therapeutic purposes and use only approved doses.

Each of these exemption categories has specific criteria that must be met to qualify for the exemption.

IND New Drug Application

The FDA provides specific instructions for completing the IND application. Anyone unsure about whether their clinical investigation is exempt from IND should submit an application, anyway. In the screening process, the FDA will flag unnecessary applications and issue a notice of exemption.