FDA regulates scientific studies that are designed to develop evidence to support the safety and effectiveness of investigational drugs (human and animal), biological products, and medical devices. Physicians and other qualified experts ("clinical investigators") who conduct these studies are required to comply with applicable statutes and regulations. These laws and regulations are intended to ensure the integrity of clinical data on which product approvals are based and to help protect the rights, safety, and welfare of human subjects.
The following resources are provided to help investigators, sponsors, and contract research organizations who conduct clinical studies on investigational new drugs comply with U.S. law and regulations covering good clinical practice (GCP).
- Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials
- Guidance for Institutional Review Boards and Clinical Investigators
- FDA Compliance Program 7348.809 - BIMO for Institutional Review Boards
- Guidances and Enforcement Information
- Investigational New Drug Application (IND Regulations) (21 CFR Part 312)
- Regulations for Applications for FDA Approval to Market a New Drug (NDA Regulations) (21 CFR Part 314)