General Provisions

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Animal Drugs, Feeds, and Related Products
  6. New Animal Drug Applications
  7. General Provisions

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Section
514.1

Applications.

Section
514.3

Definitions.

Section
514.4

Substantial evidence.

Section
514.5

Presubmission conferences.

Section
514.6

Amended applications.

Section
514.7

Withdrawal of applications without prejudice.

Section
514.8

Supplements and other changes to an approved application.

Section
514.11

Confidentiality of data and information in a new animal drug application file.

Section
514.12

Confidentiality of data and information in an investigational new animal drug notice.

Section
514.15

Untrue statements in applications.