All FDA forms listed below may be downloaded directly from the FDA Forms website. The site also includes instructions and/or guidance for each of the forms referenced.
The most frequently used FDA forms associated with investigator-sponsored INDS are:
- FDA Form 1571, "Investigational New Drug Application"
- FDA Form 1572, "Statement of Investigator"
- FDA Form 3500A, MANDATORY MedWatch Reporting
(Please note: This is not the same as FDA Form 3500, VOLUNTARY MedWatch Reporting.)
- FDA Form 3674, "Certification of Compliance with Requirements of ClinicalTrials.gov Data Bank"