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.

• Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.
• Source: 52 FR 8831, Mar. 19, 1987, unless otherwise noted.

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

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