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Compassionate Use Navigator — How Kids v Cancer can help

Need assistance? Please contact: Elena Gerasimov, Program Director, at elena@kidsvcancer.org

Our goal is to save you time and make it easier to apply for access to investigational drugs. Our services are free. We can:

1. Provide live assistance and answer general questions about the compassionate use application process.
2. Provide pharmaceutical companies’ contact information.
3. Guide you on what to include in your communication with a drug company;  assist you in understanding the criteria that the company may consider when reviewing the application; provide a sample letter to a drug company requesting compassionate use access; review the request to the company before it is sent.
4. Help find the right person at FDA; assist with completing or reviewing the paperwork needed for FDA authorization. We provide FDA forms and FDA guidances.
5. Help locate a commercial IRB if your practice is not associated with an IRB; provide a database of registered IRBs, and a sample informed consent.
6. Provide timeline and forms for mandatory safety reporting.
7. Need something else? Ask us if we can help.

Forms and Handouts

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:
FDA Form 3926 – Individual Patient Expanded Access Application
Form 1571 – Investigational New Drug Application and Instructions for completing Form 1571 (being 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
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:
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

The Compassionate Use Navigator cannot evaluate the merits of compassionate use requests or provide medical expertise regarding treatment options.