|
Table of Contents
|
|
|
Information and Requirements for Review and Approval of New Animal Drug Applications (NADAs)
As mandated by the Federal Food, Drug and Cosmetic Act, a new animal drug may not be sold in interstate commerce unless it is the subject of a New Animal Drug Application (NADA).
What does an approved NADA mean? It means the product is safe and effective for its intended use and that the methods, facilities and controls used for the manufacturing, processing and packaging of the drug are adequate to preserve its identity, strength, quality and purity.
Veterinary Drug Approval Process
-
The veterinary drug approval process consists of a series of consultative procedures and reviews. This page lists the regulations, guidance documents, instructions and forms necessary for the submission of an application.
-
CVM has entered into a formal collaboration to identify and address problems regarding the quality of new animal drug applications submitted by sponsors to FDA for review. The overall purpose of this collaboration is to improve communications between CVM and the animal drug sponsor and help drug sponsors better understand regulatory considerations resulting in their developing a quality animal drug submission. Please see the abstract for the CRADA for more information.
-
Information on the review and approval process for generic animal drugs can be found on the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) page.
-
Information on the review and approval process for drugs for minor species and/or minor uses can be found on the Minor Uses/Minor Species (MUMS) page.
Federal Law/U.S. Code of Federal Regulations
(Note: For your convenience we have included the FFDCA Table of Contents
-
Federal Food, Drug, and Cosmetic Act, As Amended - Section 701 Chapter VII - General Authority
-
U.S. Code: Title 21-Food and Drugs Part 58--Good Laboratory Practice For Nonclinical Laboratory Studies
-
U.S. Code: Title 21-Food and Drugs Part 210--Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs; General
-
U.S. Code: Title 21-Food and Drugs Part 211--Current Good Manufacturing Practice For Finished Pharmaceuticals
-
U.S. Code: Title 21-Food and Drugs Part 225--Current Good Manufacturing Practice For Medicated Feeds
-
U.S. Code: Title 21-Food and Drugs Part 226--Current Good Manufacturing Practice For Type A Medicated Articles
-
U.S.Code: Title 21-Food and Drugs Part 201--Labeling
-
U.S. Code: Title 21-Food and Drugs Part 511 – New Animal Drugs for Investigational Use
- U.S. Code: Title 21-Food and Drugs
Part 514 – New Animal Drug Applications
Forms and Electronic Forms Submission
Guidance Documents
- Guidance for Industry #41: Draft Guideline for Formatting, Assembling, and Submitting New Animal Drug Applications - Withdrawn 3/2002
- Guidance For Industry #42: Animal Drug Manufacturing Guidelines
- Guidance For Industry #48: Guidance for Industry: Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products
-
Guidance For Industry #57: Guidance for Industry for the Preparation and Submission of Veterinary Master Files
-
Guidance For Industry #58: Good Target Animal Study Practices - Withdrawn 12/22/2004 | htm | | pdf |
-
Guidance for Industry #82: Development of Supplemental Applications for Approved New Animal Drugs - Final Guidance | pdf | | doc |
-
Guidance for Industry #106: Use of Published Literature in Support of New Animal Drug Approval | wpd | | pdf |
-
Guidance for Industry and Reviewers #119: How the Center for Veterinary Medicine Intends to Handle Deficient Submissions Filed During the Investigation of a New Animal Drug - Final Guidance, August 29, 2002 | doc | | pdf |
-
Guidance for Industry #121:Expedited Review for New Animal Drug Applications for Human Pathogen Reduction Claims, March 6, 2001 | doc | | pdf |
-
Guidance for Industry 123 - Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for Use in Animals, Final, January 5, 2006 [html] [doc] [pdf]
-
Guidance for Industry #132: The Administrative New Animal Drug Application Process - Draft, November 6, 2002 | doc | | pdf |
Additional Information
-
Docket No. 2004D-0468, CVM 200548. Guidance for Industry on Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs for Use in Animals; Availability. Page 350 [FR Doc. E5-08223] January 4, 2006 [TXT] [PDF] [PRE-PUB]
-
CVM Update - Draft Guidance for Drug Sponsors on NSAIDs for Use in Animals Available for Review and Comment, November 10, 2004
-
FR Notice: Docket No. 2004D-0468, CVM 200091. Draft Guidance for Industry on Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs for Use in Animals; Availability. Pages 65202-65203 [FR Doc. 04-24995] November 10, 2004 | htm | | pdf | Comments due January 24, 2005
-
CVM Update: FDA Issues Final Rules for NADA Presubmission Conferences, August 18, 2004
-
FR Notice: Docket No. 2000N-1399, CVM 2000133. Presubmission Conferences. Pages 51162-51171 [FR Doc. 04-18846] August 18, 2004 [TXT] [PDF] Final Rule Effective date November 1, 2004
-
CVM Update: FDA Revises the Definition of the Term "No Residue"
-
FR Notice: Docket No. 01N-0401, CVM 200262. Revision of the Definition of the Term No Residue in the New Animal Drug Regulations. Pages 78172-78174 [FR Doc. 02-32216] December 23, 2002[TXT] [PDF] Effective January 23, 2003
-
CVM Update: Guidance Available on Developing Supplemental NADAs
-
FR Notice: Docket No. 99N-2912, CVM 200065. Final Guidance for Industry on the Development of Supplemental Applications for Approved New Animal Drugs; Availability. Page 68142 [FR Doc. 02-28472 ] November 8, 2002 | htm | | pdf |Comments November 8, 2003
-
CVM Update - Draft Guidance on Administrative NADA Process Available for Comment, November 7, 2002
-
FR Notice: Docket No. 02D-0449, CVM 200097. Draft Guidance for Industry #132: The Administrative New Animal Drug Application Process; Availability. Pages 67631-67632 [FR Doc. 02-28257] November 6, 2002 | htm | | pdf | Comments on the draft guidance by January 21, 2003 Comments on the collection requirements by January 6, 2003
Web Page Updated by hd - November 17, 2008, 9:00 PM ET
|
|