Source: https://ecfr.io/Title-21/se21.5.312_1310
Timestamp: 2019-10-19 17:45:19
Document Index: 96309043

Matched Legal Cases: ['§312', 'art 312', '§312', 'art 312', '§312', 'art 312', '§312', '§312', '§312', '§312', '§312', '§312', '§312', '§312']

[21 CFR §312.310] Title 21 Part 312 → Subpart I → §312.310 : Code of Federal Regulations ';
Title 21 Part 312 → Subpart I → §312.310
Title 21 → Chapter I → Subchapter D → Part 312 → Subpart I → §312.310
§312.310 Individual patients, including for emergency use.
(a) Criteria. The criteria in §312.305(a) must be met; and the following determinations must be made:
(b) Submission. The expanded access submission must include information adequate to demonstrate that the criteria in §312.305(a) and paragraph (a) of this section have been met. The expanded access submission must meet the requirements of §312.305(b).
(4) When a significant number of similar individual patient expanded access requests have been submitted, FDA may ask the sponsor to submit an IND or protocol for the use under §312.315 or §312.320.
(1) Emergency expanded access use may be requested by telephone, facsimile, or other means of electronic communications. For investigational biological drug products regulated by the Center for Biologics Evaluation and Research, the request should be directed to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, 240-402-8010 or 1-800-835-4709, e-mail: [email protected] For all other investigational drugs, the request for authorization should be directed to the Division of Drug Information, Center for Drug Evaluation and Research, 301-796-3400, e-mail: [email protected] After normal working hours (8 a.m. to 4:30 p.m.), the request should be directed to the FDA Emergency Call Center, 866-300-4374, e-mail: [email protected]
(2) The licensed physician or sponsor must explain how the expanded access use will meet the requirements of §§312.305 and 312.310 and must agree to submit an expanded access submission within 15 working days of FDA's authorization of the use.