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Table of Contents
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Information and Requirements for Review and Approval
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
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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.
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A detailed explanation is given in a PowerPoint presentation
titled Overview
of the Animal Drug Approval Process by Steven D. Vaughn,
D.V.M., former Director, Division of Therapeutic Drugs for
Food Animals, and now Director, Office of New Animal Drug
Evaluation.
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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.
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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.
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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
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Federal Food, Drug, and Cosmetic Act, As Amended - Section
701
Chapter VII - General Authority
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U.S. Code: Title 21-Food and Drugs
Part
58--Good Laboratory Practice For Nonclinical Laboratory
Studies
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U.S. Code: Title 21-Food and Drugs
Part
210--Current Good Manufacturing Practice In Manufacturing,
Processing, Packing, Or Holding Of Drugs; General
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U.S. Code: Title 21-Food and Drugs
Part
211--Current Good Manufacturing Practice For Finished
Pharmaceuticals
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U.S. Code: Title 21-Food and Drugs
Part
225--Current Good Manufacturing Practice For Medicated
Feeds
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U.S. Code: Title 21-Food and Drugs
Part
226--Current Good Manufacturing Practice For Type A
Medicated Articles
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U.S.Code: Title 21-Food and Drugs
Part
201--Labeling
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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
(Note: These documents are in pdf format only )
Guidance Documents
- Guidance for Industry #41: Draft
Guideline for Formatting, Assembling, and Submitting New Animal
Drug Applications
- 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
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Guidance For Industry #57: Guidance
for Industry for the Preparation and Submission of Veterinary
Master Files
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Guidance For Industry #58: Good
Target Animal Study Practices
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Guidance for Industry #82: Development of Supplemental
Applications for Approved New Animal Drugs - Final Guidance
| pdf | | doc |
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Guidance for Industry #106: Use of Published Literature
in Support of New Animal Drug Approval
| wpd | |
pdf |
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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 |
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Guidance for Industry #121:Expedited Review for New Animal
Drug Applications for Human Pathogen Reduction Claims, March
6, 2001 | doc
| | pdf |
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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 - Draft
Guidance, March 23, 2001 | doc
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Guidance for Industry #132: The Administrative New Animal
Drug Application Process - Draft, November 6, 2002
| doc | | pdf
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Additional Information
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CVM Update: FDA Issues Final Rules for NADA Presubmission Conferences, August 18, 2004
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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
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CVM Update: FDA Revises
the Definition of the Term "No Residue"
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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
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CVM Update: Guidance Available
on Developing Supplemental NADAs
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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
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|Comments November 8, 2003
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CVM Update - Draft Guidance
on Administrative NADA Process Available for Comment,
November 7, 2002
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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 mdt, August 19, 2004, 1:07 PM ET
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