Looking for regulatory relief? See if your product and proposed study can be conducted without an IND.
Using an Approved Drug
Clinical studies using approved drugs are exempt from IND regulations when all of the following conditions are met:
- The study is not intended to used in a marketing application or to support a significant change in the labeling for the drug
- The study is not intended to support a significant change in the product’s advertising
- The study does not involve a route of administration, dosage level, patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) of the product
- The study is conducted in compliance with 21 CFR Parts 50 and 56 (Human subject protection)
- The study is conducted in compliance with 21 CFR 312.7 (Promotion and charging for investigational drugs)
- 21 CFR Part 312.2 (b) (1)
Using Only Placebo
A clinical study involving use of a placebo is exempt if the study does not otherwise require submission of an IND.