FDA guidance

FDA overview

The FDA provides oversight for clinical trials of investigational drugs, biologic products and medical devices.

Useful links

• Running clinical trials
• FDA educational materials
• FDA compliance and enforcement information
• FDA alerts

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
• Protection of human subjects 21 CFR 50
• Financial disclosure by clinical investigators 21 CFR 54
• Institutional review boards 21 CFR 56
• Investigational new drug application 21 CFR 312
• Investigational device exemptions 21 CFR 812

FDA guidance documents and information sheets

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

Highlighted guidance

• Guidance for industry: Investigator responsibilities-protecting the rights, safety and welfare of study subjects
• FDA guidance for clinical investigators, sponsors and IRBs: Adverse event reporting to IRBs - improving human subject protection
• Financial disclosure by clinical investigators
• ICH GCP E6 - Good clinical practice: Consolidated guidance

Guidance on FDA form completion

• Completion guidelines for FDA forms 1571, 1572 and 3674
• Frequently asked questions - FDA form 1572

Guidance on clinical trial registration on ClinicalTrials.gov

• Certification requirements to accompany drug, biologics and device submissions in association with Clinical Trial Registrations

Device-related guidance

• Humanitarian device exemptions regulation: Q&A
• Investigational device advice

FDA forms/templates

The FDA requires that study sponsors and clinical investigators complete forms specific to the type of study that is being conducted.

• FDA form 1571 - Information for sponsor-investigators submitting investigational new drug applications
• FDA form 1572 - Statement of investigator
• FDA Form 3454 - Certification of absence of reportable financial interest
• FDA Form 3455 - Financial disclosure
• FDA Form 3674 - Certificate of compliance with requirements of ClinicalTrials.gov data bank

Adverse event reporting

• Instructions for completing MedWatch 3500A

FDA compliance findings

The most recent FDA warning letters can be accessed on the FDA website.

• FDA most recent warning letters