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Regulations last checked for updates: May 15, 2025

Title 21 - Food and Drugs last revised: May 12, 2025
All TitlesTitle 21Chapter IPart 312Subpart I - Subpart I—Expanded Access to Investigational Drugs for Treatment Use
  • § 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: 52 FR 8831, Mar. 19, 1987, unless otherwise noted.
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