Drugs
Emergency New Drug Application Eligibility Tool (text version)
Question 1: Is the patient's case an emergency?
If YES, go to Question 2.
If NO, Emergency IND application is NOT an option.
Possible alternatives include:
1. Use of approved treatments
2. Enrollment of the patient in an ongoing clinical trial or an ongoing expanded access program
OR
3. Consider designing and conducting an exploratory clinical trial
Question 2: Is the drug available by other means?
(such as an approved drug, ongoing trial or another expanded access program)
If NO, go to Question 3.
If YES, Emergency IND application is NOT an option.
Possible alternatives include:
1. Use of approved treatments
2. Enrollment of the patient in an ongoing clinical trial or an ongoing expanded access program
OR
3. Consider designing and conducting an exploratory clinical trial
Question 3: Do ALL of the following apply to your case?
- The disease is life-threatening or will lead to severe disability
- No approved therapeutic alternative is available
- The risk of complications from the disease is higher than the risk of toxicity from this investigational treatment
- IND supplier (e.g. product’s manufacturer) agrees to supply the drug and to provide a letter of authorization for reference to the existing IND application or Drug Master File (whichever is applicable)
If YES, Call FDA to request opening of an
Emergency Investigational New Drug (IND) application
During Business Hours (Mon-Fri: 8:30 a.m. to 5 p.m. E.T.):
Division of Drug Information (888) 463-6332 or (301) 796-3400
or the appropriate Review Division in the Office of New Drugs in CDER
After Hours:
FDA Office of Crisis Management & Emergency Operations Center
(866) 300-4374 or (301) 796-8240
If NO, Emergency IND application is NOT an option.
Possible alternatives include:
1. Use of approved treatments
2. Enrollment of the patient in an ongoing clinical trial or an ongoing expanded access program
OR
3. Consider designing and conducting an exploratory clinical trial
