Application steps explained in one document (PDF)
At a Glance:
Compassionate Use Application Flowchart
Timeline for Emergency Application Submission
Safety Reporting Requirements
Templates:
Letter to a Drug Company requesting compassionate use access
Letter of Authorization from a drug company
Sample Informed Consent
FDA Forms:
Form 3926 Individual Patient Expanded Access IND and Instructions for Form 3926
Form 1571 – Investigational New Drug Application and Instructions for completing Form 1571 (replaced by Form 3926)
Form 1572 – Statement of Investigator and Instructions for completing Form 1572
Physician’s Checklist for an IND Application for Emergency Treatment
Form 3500A MedWatch for Mandatory Reporting and Instructions for completing Form 3500A
Physician fact sheet and application checklist for expanded access
FDA Guidances:
Expanded Access to Investigational Drugs for Treatment Use Q & As (updated Oct. 2017)
Safety Reporting Requirements for INDs and BA/BE Studies
Adverse Event Reporting to IRBs
Charging for Investigational Drugs under an IND – Q & A
IRB Resources:
Waiver of IRB Requirements for Drug and Biological Product Studies (FDA Information Sheet guidance)
Sample overview of IRB application procedure (every institution’s IRB rules and requirements are different)
Sample emergency use guidance
Search the database of registered IRBs
Search for a commercial IRB
Requirements for using non-local IRB