Pluristem Therapeutics Inc (PSTI)

[Auto1]

https://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm

U.S. Department of Health and Human Services
U.S. Food and Drug Administration
Expanded access (sometimes called “compassionate use”) is the use of investigational drugs, biologics or medical devices outside the clinical trial setting for treatment purposes. Expanded access may be appropriate when all the following apply:

Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
Patient enrollment in a clinical trial is not possible.
Potential patient benefit justifies the potential risks of treatment.
Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication

Information for Patients, Physicians and Industry Patients
Learn about what your physician should do before submitting a request for individual patient expanded access use of an investigational medical product, who may be eligible for expanded access, associated costs, FDA contacts and more[color=red][/color]

Physicians
Learn about your responsibilities under the expanded access pathway, how to submit a request for expanded access for an individual patient (including for emergency use), which forms to use, FDA contacts and more.

Industry
Learn about current regulations, what information is required when you provide access to investigational medical products under an individual patient expanded access IND, and view an example of wording that could be used for a Letter of Authorization, FDA contacts and more.

Key Contact Information
1. During Normal Business Hours (8 a.m. - 4:30 p.m. ET, weekdays)
For specific questions during normal business hours:
Investigational drugs: 301-796-3400 or [e-mail] [CDER's Division of Drug Information], or contact the appropriate review division, if known
Investigational medical devices: 301-796-7100 or [e-mail] [CDRH's Division of Industry and Consumer Education]
Investigational biologics: 240-402-8020 or 800-835-4709 or [e-mail] [CBER's Office of Communication, Outreach and Development]
For general questions, or if you are unsure of who to contact, contact the Patient Affairs Staff at 301-796-8460 or [e-mail].

2. After 4:30 p.m. ET weekdays and all day on weekends
For emergency requests for all medical products (drugs, biologics, and medical devices) contact FDA's Emergency Call Center at 866-300-4374.
For additional contact information and mailing addresses for forms: Expanded Access Contact Information