NON-EMERGENCY USE OF A DRUG OR BIOLOGIC
The non-emergency use provision can be used when the following conditions apply:
- You wish to use the unapproved drug or biologic;
- The patient has a serious disease or condition for which there is no comparable alternative;
- The patient is unable to qualify for a clinical trial using the unapproved drug or biologic;
- The potential benefits justify the potential risks of the treatment; and,
- Providing the unapproved drug or biologic will not interfere with the initiaion, conduct, or completion of clinial investigations of the drug or biologic.
The FDA must provide authorization for the use of the unapproved drug or biologic either to the Physician or the Sponsor, depending who holds the IND, prior to use.
| 1. |
The Physician must request approval from the Manufacturer/Sponsor of the drug or biologics for non-emergency use under the company's IND. If the Manufacturer/Sponsor does not have an IND, the Physician should obtain a Letter of Authorization (LOA) from Medical Developer/Sponsor for use of the drug or biologic. If a LOA is not available or the Manufacturer/Sponsor declines permission to use the drug or biologic, sufficient information must be submitted in Form 3926 to assure the FDA of the product's quality. |
| 2. |
If the Investigator holds the IND, the Physician must support Form 3926 and the LOA from the Manufacturer/ Sponsor to the FDA via mail. |
| 3. |
The Physician must submit to the IRB the Before Use section of the Expanded Access to a Test Article (EATA) application in Kuali. Physician may request authorization from the FDA to obtain concurrence from the IRB Chair/designated member in lieu of Full Board Review. This should be documented in the application. |
| 4. |
Physician must obtain informed consent from the individual receiving the drug or biologic. The Non-Emergency Use of a Test Article Consent Form can be used if one is not provided by sponsor. |
| 5. |
30 days after application is sent to FDA, or sooner if contacted by the FDA, the drug/biologic can be shipped and treatment can begin. |
|
6. |
Within 5 business days of use, the Physician should follow-up with the IRB by submitting the After Use section of the EATA application in Kuali. |
| 7. |
Also within 5 business days, the Physician should notify the Manuacturer/Sponsor of use. |
| 8. |
If the Physician holds the IND, the Physician is responsible for submitting a follow-up report to the FDA using Form 3926 as applicable. |
| 1. |
The Physician must request approval from the Manufacturer/Sponsor of the drug or biologics for non-emergency use under the company's IND. If the Manufacturer/Sponsor does not have an IND, the Physician should obtain a Letter of Authorization (LOA) from Medical Developer/Sponsor for use of the drug or biologic. If a LOA is not available or the Manufacturer/Sponsor decluses permission to use the dru or biologic, sufficient information must be submitted in Form 1571 and Form 1572 to assure the FDA of the product's quality. |
| 2. |
If the Physician holds the IND, the Physician must submit must submit Form 1571 and Form 1572 in triplicate (1 original and 2 copies), and the LOA to the FDA via mail. |
| 3. |
Prior to treatment, the Physician must submit to the IRB a Full Board application in Kuali. |
| 4. |
Physician must obtain informed consent from the individual receiving the drug or biologic. The Non-Emergency Use of a Test Article Consent Form can be used if one is not provided by sponsor. |
| 5. |
30 days after application is sent to FDA, or sooner if contacted by the FDA, the drug/biologic can be shipped and treatment can begin. |
|
6. |
Within 5 business days of use, the Physician should follow-up with the IRB. |
| 7. |
Also within 5 business days, the Physician should notify the Manuacturer/Sponsor of use. |
| 8. |
If the Physician holds the IND, the Physician is responsible for submitting a follow-up report to the FDA using Form 1571 as applicable. |
