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Friday, April 19, 2024

Program of IND/IDE Assistance (PIA)

• Home
• Guidance
  • Determining the Need for an IND
  • Overview of IND Regulations
  • Investigator/Sponsor Obligations
• FDA Requirements for Registration
  • Registration of studies with ClinicalTrials.gov
• Filing and Forms
  • Filing an IND
  • Forms
  • Documents
  • IND Submission Process
• Conduct and Oversight Services from PIA
  • Review of submission prior to mailing
  • Conduct of the IND Protocol
  • Monitoring and Sponsor's Obligations
  • Annual Reports and Amendments
  • Adverse Events and Problems
  • Quality Assurance/Audits
  • Assistance Scheduling FDA Meetings
  • Preparing for an FDA Audit
  • FDA's IND Regulations
  • Registration of trials with ClinicalTrials.gov
• FAQ's about the IND and IDE Application Process
• Quick Links to Forms

Quick Links to Forms

• Form FDA 1571
• Form FDA 1572
• FDA Guidelines for completing forms 1571/1572
• Medwatch Form
• Form FDA 3674

Contact Us: IND Specialist/Monitor 212-327-7408 or Kimberly.Bazylewicz@rockefeller.edu

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