Title 21

PART 312 SUBPART E

Subpart E - Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses Authority:21 U.S.C. 351, 352, 353, 355, 371; 42 U.S.C. 262. Source:53 FR 41523, Oct. 21, 1988, unless otherwise noted.

21:5.0.1.1.3.5.1.1SECTION 312.80
   312.80 Purpose.
21:5.0.1.1.3.5.1.2SECTION 312.81
   312.81 Scope.
21:5.0.1.1.3.5.1.3SECTION 312.82
   312.82 Early consultation.
21:5.0.1.1.3.5.1.4SECTION 312.83
   312.83 Treatment protocols.
21:5.0.1.1.3.5.1.5SECTION 312.84
   312.84 Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses.
21:5.0.1.1.3.5.1.6SECTION 312.85
   312.85 Phase 4 studies.
21:5.0.1.1.3.5.1.7SECTION 312.86
   312.86 Focused FDA regulatory research.
21:5.0.1.1.3.5.1.8SECTION 312.87
   312.87 Active monitoring of conduct and evaluation of clinical trials.
21:5.0.1.1.3.5.1.9SECTION 312.88
   312.88 Safeguards for patient safety.