An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: Investigational New Drug Applications (INDs) for CBER-Regulated Products

Clinical Investigator Information

Conducting a Clinical Investigation

Clinical Trials and Human Subject Protection
FDA's Office of Science and Research
Clinical Trials Guidance Documents
Section 8200: Investigational New Drugs (INDs)
Standard Operating Policies and Procedures (CBER)
Clinical Hold / Refusal to File Meetings

Compliance, Enforcement, Investigations

Rules

Top