Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs), including:

• Mailing addresses
• Instructions for forms
• FDA's receipt of the IND

 Forms:

• Form FDA 1571 (PDF - 221KB): Investigational New Drug Application (IND)
• Form FDA 1572 (PDF - 208KB): Statement of Investigator
• Form FDA 3674 (PDF - 411KB): Certification of Compliance
• Form FDA 3454 (PDF - 47KB): Certification: Financial Interests and Arrangements of Clinical Investigators
• Form FDA 3455 (PDF - 56KB): Disclosure: Financial Interest and Arrangements of Clinical Investigators
• Form FDA 3500 (PDF - 1MB): MedWatch Medical Product Reporting Program - Voluntary
• Form FDA 3500A (PDF - 903KB): Medwatch Medical Products Reporting Program - Mandatory
• Form FDA 3926 (PDF - 473KB) : Individual Patient Expanded Access Applications 
  • Instructions
     

For electronic form submissions, see Electronic Regulatory Submissions.