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LII
Electronic Code of Federal Regulations (e-CFR)
Title 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D—DRUGS FOR HUMAN USE
PART 312—INVESTIGATIONAL NEW DRUG APPLICATION
Subpart I—Expanded Access to Investigational Drugs for Treatment Use
21 CFR Subpart I - Subpart I—Expanded Access to Investigational Drugs for Treatment Use
CFR
§ 312.300 General.
§ 312.305 Requirements for all expanded access uses.
§ 312.310 Individual patients, including for emergency use.
§ 312.315 Intermediate-size patient populations.
§ 312.320 Treatment IND or treatment protocol.
Source:
74 FR 40942
, Aug. 13, 2009, unless otherwise noted.