FDA guidance
FDA overview
The FDA provides oversight for clinical trials of investigational drugs, biologic products and medical devices.
Useful links
- Clinical trials and human subject protection
- Good clinical practice education materials
- FDA compliance and enforcement information
FDA regulations
Clinical trials involving investigational drugs, biologics and/or devices are governed by specific FDA regulations. Numerous parties involved in the clinical trials process, including study sponsors, principal investigators and institutional review boards, are subject to applicable FDA regulations.
- FDA regulations related to good clinical practice and clinical trials
- Electronic records; electronic signatures 21 CFR 11
- Financial disclosure by clinical investigators 21 CFR 54
FDA guidance documents
The FDA provides guidance documents that describe the FDA's current thinking about issues related to FDA-regulated clinical trials. In addition, the FDA publishes information sheets that provide guidance and recommendations for IRBs, clinical investigators and sponsors to help them fulfill their responsibilities to protect human subjects who participate in FDA-regulated research.
- FDA guidance documents, information sheets and notices
- Guidance for industry: Investigator responsibilities-protecting the rights, safety and welfare of study subjects
- ICH GCP E6 - Good clinical practice: Consolidated guidance