U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 28, 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.
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