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Regulations last checked for updates: May 14, 2025

Title 21 - Food and Drugs last revised: May 12, 2025
All TitlesTitle 21Chapter IPart 514Subpart A - Subpart A—General Provisions
  • § 514.1 - Applications.
  • § 514.3 - Definitions.
  • § 514.4 - Substantial evidence.
  • § 514.5 - Presubmission conferences.
  • § 514.6 - Amended applications.
  • § 514.7 - Withdrawal of applications without prejudice.
  • § 514.8 - Supplements and other changes to an approved application.
  • § 514.11 - Confidentiality of data and information in a new animal drug application file.
  • § 514.12 - Confidentiality of data and information in an investigational new animal drug notice.
  • § 514.15 - Untrue statements in applications.
authority: 21 U.S.C. 321,331,351,352,354,356a,360b,360ccc,371,379e,381
source: 40 FR 13825, Mar. 27, 1975, unless otherwise noted.
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