Description
This guidance is intended for sponsors seeking to combine fully approved and conditionally approved indications on a single new animal drug product label and labeling (dual labeling). The term “full approval” or “fully approved” is used herein when referring to an approval of a New Animal Drug Application (NADA) submitted under section 512(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The term “conditional approval” or “conditionally approved” is used when referring to approval of a Conditional NADA (CNADA) under section 571 of the FD&C Act.
Scope & Applicability
Product Classes
1The category of products covered by this guidance.
Stakeholders
1Entity responsible for submitting applications under section 524B
Related CFR Sections (2)
- 21CFR514.80§ 514.80 Records and reports concerning experience with approved new animal drugs.
The following table outlines the purpose for each paragraph of this section:Read full regulation →
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
See Also (8)
- CVM GFI #188 Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine (Status: Final)
- CVM GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process (Status: Final)
- CVM GFI #117 (VICH GL24) Management of Adverse Event Reports (AER's) (Status: Draft)
- CVM GFI #218 Cell-Based Products for Animal Use (Status: Final)
- CVM GFI #231 Distributor Labeling for New Animal Drugs (Status: Final)
- CVM GFI #252 Small Entity Compliance Guide Antimicrobial Animal Drug Sales and Distribution Reporting (Status: Final)
- CVM GFI #240 Proprietary Names for New Animal Drugs (Status: Final)
- CVM GFI #256 - Compounding Animal Drugs from Bulk Drug Substances (Status: Final)