Title 21

PART 312 SUBPART I

Subpart I - Expanded Access to Investigational Drugs for Treatment Use Source:74 FR 40942, Aug. 13, 2009, unless otherwise noted.

21:5.0.1.1.3.9.1.1SECTION 312.300
   312.300 General.
21:5.0.1.1.3.9.1.2SECTION 312.305
   312.305 Requirements for all expanded access uses.
21:5.0.1.1.3.9.1.3SECTION 312.310
   312.310 Individual patients, including for emergency use.
21:5.0.1.1.3.9.1.4SECTION 312.315
   312.315 Intermediate-size patient populations.
21:5.0.1.1.3.9.1.5SECTION 312.320
   312.320 Treatment IND or treatment protocol.