FDA Reviews Clinical Research Approval Process

The U.S. Food & Drug Administration (FDA) has contracted with Eastern Research Group, Inc. (ERG) to review the FDA’s investigational new drug (IND) approval process. The IND phase of drug development is when human trials of new drugs are conducted. The FDA receives 4,000 IND requests a year.

In order for a new drug to be approved, sponsors must submit an IND application to the FDA before starting clinical research. If the FDA does not object or ask any questions during a 30-day window, clinical research may begin. Clinical research then goes through a four-stage approval process to determine safety, dosage, efficiency, and side effects.

Currently, ERG is conducting surveys and interviews with sponsors of IND requests to identify best practices and assess areas for improvement in the process. The FDA will publish the report, when completed, on its website. In the meantime, progress updates on ERG’s review will be available on the Office of Information and Regulatory Affairs’ reginfo.gov website.