Phase 1 IND Federal Regulations

Section 21 of the Code of Federal Regulations (CFR) contains most regulations pertaining to food and drugs. The regulations document all actions of all drug sponsors that are required under Federal law.

Regulations listed on this page apply to the IND process: 

Contact Us
Questions? Contact the Phase 1 Clinical Trials Support Team:
Phone: 240-276-9358
Email: Phase1Questions@fda.hhs.gov

Regulation	Number
Investigational New Drug Application	Part 312
Good Laboratory Practice for Nonclinical Laboratory Studies	Part 58
Institutional Review Boards	Part 56
Financial Disclosure by Clinical Investigators	Part 54
Protection of Human Subjects	Part 50
Electronic Records; Electronic Signatures	Part 11
Current Good Manufacturing Practice for Finished Pharmaceuticals	Part 211
Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General	Part 210
Labeling	Part 201
Orphan Drugs	Part 316

---

Regulatory References on FDA.gov

• Formal Meetings and Requests for Feedback for CBER-Regulated Products
• Investigational New Drug Applications (INDs) for CBER-Regulated Products
• OTP Pre-IND Meetings (CBER)
• IND Application Reporting: Safety Reports (CDER)
• Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs) (CDER)
• IND Applications for Clinical Investigations: Regulatory and Administrative Components (CDER)
• Investigational New Drug (IND) and Emergency Investigational New Drug (EIND) Application Information (CDER)
• Current Good Manufacturing Practice (CGMP) Regulations (CDER)
• CMC Information for Original FIH Phase 1 INDs for CDER-Regulated Recombinant Biological Products (CDER)
• IND Applications for Clinical Investigations: Chemistry, Manufacturing, and Control (CMC) Information (CDER)
• IND Applications for Clinical Investigations: Clinical Protocols (CDER)
• IND Applications for Clinical Investigations: Clinical Components (CDER)
• IND Applications for Clinical Investigations: Previous Human Experience with the Investigational Drug (CDER)
• IND Application Reporting: Protocol Amendments (CDER)
• IND Application Reporting: Overview (CDER)
• IND Application Reporting: Information Amendments (CDER)
• IND Application Reporting: Annual Reports (CDER)
• IND Applications for Clinical Investigations: Pharmacology and Toxicology (PT) Information (CDER)
• CDER/Office of New Drugs Streamlined Nonclinical Studies and Acceptable New Approach Methodologies (NAMs)
• Small Business and Industry Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting (CDER)
• Investigational New Drug (IND) Application (CDER)