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Regulations last checked for updates: Jun 14, 2025
Title 21 - Food and Drugs last revised: Jun 03, 2025
All Titles
Title 21
Chapter I
Part 312
Subpart E - Subpart E—Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses
§ 312.80 - Purpose.
§ 312.81 - Scope.
§ 312.82 - Early consultation.
§ 312.83 - Treatment protocols.
§ 312.84 - Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses.
§ 312.85 - Phase 4 studies.
§ 312.86 - Focused FDA regulatory research.
§ 312.87 - Active monitoring of conduct and evaluation of clinical trials.
§ 312.88 - Safeguards for patient safety.
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.
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