Records and Reports

  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. New Drugs
  7. Records and Reports

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Section
310.305

Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.

Section
310.306

Notification of a permanent discontinuance or an interruption in manufacturing of marketed prescription drugs for human use without approved new drug applications.