Expanded Access to Investigational Drugs for Treatment Use

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Drugs for Human Use
  6. Investigational New Drug Application
  7. Expanded Access to Investigational Drugs for Treatment Use

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Section
312.300

General.

Section
312.305

Requirements for all expanded access uses.

Section
312.310

Individual patients, including for emergency use.

Section
312.315

Intermediate-size patient populations.

Section
312.320

Treatment IND or treatment protocol.