21 CFR Part 514 - Subpart A - General Provisions
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- § 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.