CVM/Office of New Animal Product Evaluation (ONAPE) and Office of Generic Animal Drugs (OGAD) Reviewer's Chapter
On October 20, 2024, CVM began implementing a reorganization impacting two of our offices. We are in the process of updating FDA.gov content to reflect these changes.
1243.2000--ONAPE's and OGAD's General Review
- 1243.2010 Responsibilities for Keeping and Maintaining Records
May 19, 2023 - 1243.2020 United States (U.S.)-Based Employee and U.S. Agent Representation of Foreign Sponsors
February 15, 2024 - 1243.2030 Responding to Requests for Copies of Individual Official Communications or Administrative Document Files
October 16, 2023 - 1243.2050 Refuse to File and Refuse to Review
May 24, 2023 - 1243.2100 Eligibility for Conditional Approval Under the Expanded Conditional Approval (XCA) Criteria
February 1, 2024 - 1243.2180 Certifications for New Animal Drug Submissions and Applications
November 29, 2023 - 1243.2200 Submission and Review of Early Information (EI) to Presubmission Conferences and Protocol Review
September 29, 2023 - 1243.2341 Transfer of Ownership
March 21, 2024 - 1243.2342 Change of Sponsor Name or Address
May 24, 2023 - 1243.2400 Veterinary Master Files with Manufacturing Information
May 18, 2023 - 1243.2600 Review of ONADE-Regulated Products that Contain Nanomaterials or Otherwise Involve the Use of Nanotechnology
August 2, 2023
1243.3000--Admin Procedures for ONAPE and OGAD
- 1243.3002 Handling and Rejecting Paper Applications and Submissions
November 9, 2023 - 1243.3005 Creating Clean Electronic Files
March 29, 2023 - 1243.3009 Format and Style Conventions for Reviews and Submission Summaries
April 5, 2024 - 1243.3010 Format and Style Conventions for Letters
April 5, 2024 - 1243.3011 Voiding Submissions and Discontinuing the Review of Pending Submissions and Applications
July 30, 2025 - 1243.3013 Receiving and Responding to Informal Communication Requests Through eSubmitter
July 31, 2024 - 1243.3015 Proprietary Names
August 27, 2024 - 1243.3020 Review of Submissions in the STARS Queue
May 6, 2021 - 1243.3021 Portfolio Overview Meetings with Sponsors of New Animal Drug Application Projects
February 18, 2022 - 1243.3023 Lessons Learned Meetings for New Animal Drug Application Projects
February 17, 2022 - 1243.3024 Scheduling and Holding Meetings with Outside Parties
January 11, 2024 - 1243.3025 Preparing Meeting Documentation (i.e., Early Response Letter, Memorandum of Conference, Acknowledgement Letter, Other Review Documentation)
April 5, 2024 - 1243.3026 Assessing Submission Quality and Amending and Resetting the Clock on Submissions
July 19, 2022 - 1243.3028 Administrative Pathways for Obtaining Additional Chemistry, Manufacturing, and Controls Information
March 22, 2024 - 1243.3029 Closing Out Consulting Reviews for Submission Tracking and Reporting System (STARS) Submissions
March 22, 2024 - 1243.3030 Completing Final Action Packages for Submission Tracking and Reporting System (STARS) Submissions
July 31, 2023 - 1243.3040 Processing Suitability Petitions
July 18, 2022 - 1243.3050 Determining Technical Section Requirements for New Animal Drug Product Approval
September 29, 2023 - 1243.3051 Verifying Scope and Technical Section Status for Phased Review Projects in the End Game
December 6, 2023 - 1243.3060 Implementing Shortened Review Times for New Animal Drug Application (NADA) Reactivations and Investigational New Animal Drug (INAD) File Resubmissions Using eSubmitter
July 30, 2025 - 1243.3070 Implementing Shortened Review Times for Abbreviated New Animal Drug Applications (ANADA) Reactivations and Generic Investigational New Animal Drug (JINAD) Resubmission
March 28, 2024 - 1243.3200 Routing a Request to Obtain a Consulting Review of a Submission Tracking and Reporting System (STARS) Submission
March 18, 2024 - 1243.3210 Requesting a Quality Control Review from the Quality Assurance Team for Final Action Packages Signed by the Office or Center Director
October 18, 2023 - 1243.3215 Requesting a Quality Assurance Study Review from the Quality Assurance Team
October 19, 2023 - 1243.3250 Q Submissions: Agency-Initiated Actions
October 18, 2023 - 1243.3750 Sponsor Requests to Reserve An Application Number for a New Animal Drug or Abbreviated New Animal Drug Application
December 6, 2023 - 1243.3760 Drug Tolerance Notification Process
April 5, 2024 - 1243.3800 Reviewing, Preparing, and Routing Approval Packages for Certain Abbreviated and New Animal Drug Applications
July 28, 2025 - 1243.3801 Completing the Green Book and Animal Drugs @ FDA (GBAAD) Form
December 13, 2023 - 1243.3810 Creating and Maintaining a Reference Copy of the Currently Approved Labeling for an Application (Volume 0)
September 11, 2024 - 1243.3900 Updating the Animal Drugs @ FDA Website and Green Book
April 24, 2023
1243.4000--Investigational New Animal Drugs (INAD)
- 1243.4000 Processing a Request to Open an Investigational (INAD) or Generic Investigational New Animal Drug (JINAD) File
September 5, 2023 - 1243.4040 Investigational Food-Use Authorizations: The Role of the Target Animal Division Reviewer
April 5, 2024 - 1243.4041 Investigational Food-Use Authorizations: The Role of Division of Human Food Safety Reviewer
June 23, 2023 - 1243.4060 Review of Protocols
July 30, 2025 - 1243.4065 Requirements For Investigational New Animal Drug Exemptions
March 13, 2024 - 1243.4066 Notice of Claimed Investigational Exemption (NCIE)
March 13, 2024 - 1243.4068 Acceptability of Submissions Containing Foreign Data to Support Safety and Effectiveness
October 6, 2023 - 1243.4069 Review of Target Animal Safety or Effectiveness Data (P) Submissions
July 19, 2024 - 1243.4070 Establishing Impurity Acceptance Criteria Not Exceeding Center for Veterinary Medicine Guidance for Industry (GFI) #92 and GFI #93 Recommended Qualification Thresholds for New and Abbreviated Animal Drug Applications
May 25, 2023 - 1243.4071 Review of Raw Data for Bioequivalence Studies to Support an Abbreviated New Animal Drug Application
October 17, 2024 - 1243.4075 Post-Bioequivalence Technical Section (Post-BETS) Meetings
October 13, 2023 - 1243.4080 Labeling and All Other Information Technical Sections (Minor Technical Section or M Submissions)
December 7, 2023 - 1243.4085 All Other Information
October 20, 2023 - 1243.4090 Processing a Sponsor Request for Written Feedback Regarding Development Plans (INAD C Submission) for New Animal Drug Product Approvals
September 29, 2023 - 1243.4092 H Submissions Preceding Meetings and Protocols
October 18, 2024 - 1243.4095 Review of Raw Data Agreement H Submission for Target Animal Safety and Effectiveness Studies
December 11, 2025 - 1243.4096 Review of Raw Data for Marker Residue Depletion Studies to Support a New Animal Drug Application
July 30, 2025
1243.5000--New Animal Drug Applications (NADA)
- 1243.5704 Process for Eligible Sponsors to Obtain Conditional Approval
April 15, 2024 - 1243.5706 Meeting to Discuss Post-Approval Responsibilities for Sponsors of Conditional Approvals
July 13, 2023 - 1243.5708 Procedure for Sponsors to Maintain Conditionally Approved Products and Obtain Full Approval
May 16, 2023 - 1243.5725 Final Printed Labeling and Electronic Printed Labeling
February 16, 2024 - 1243.5730 Review of 60-Day Original Animal Drug Availability Act of 1996 (ADAA) Feed Use Combination New Animal Drug Applications (NADAs)
August 25, 2020 - 1243.5740 ANADA Memorandum Recommending Approval
November 16, 2001 - 1243.5741 Memorandum Recommending Approval (MRA) for Original and Supplemental (Abbreviated) New Animal Drug Applications ((A)NADA)
August 5, 2024 - 1243.5760 Process for Preparing an Executive Summary for a Freedom of Information Summary
December 8, 2023 - 1243.5761 Freedom of Information (FOI) Summary for Original and Supplemental New Animal Drug Applications (NADA)
August 5, 2024 - 1243.5762 Freedom of Information (FOI) Summary for an ADAA Medicated Feed Combination New Animal Drug Application
August 5, 2024 - 1243.5763 Process for Correcting Published Freedom of Information (FOI) Summaries
March 29, 2023 - 1243.5780 Exclusivity and Exclusive Marketing Rights Boilerplate for Use in the Following Documents: Memorandum Recommending Approval, Letter to Applicant, and Freedom of Information Summary
February 24, 2024 - 1243.5820 Approval Letters
April 5, 2024
1243.6000--Supplemental NADAs
- 1243.6020 Review of Abbreviated and New Animal Drug Application Labeling Supplements (NL Subclass)
July 30, 2025 - 1243.6030 Review of Labeling Changes in Manufacturing Supplements
July 30, 2025 - 1243.6040 Review of Abbreviated and New Animal Drug Application 60- and 180-Day Non-Fee Prior Approval Labeling Supplements (NF Subclass)
March 29, 2024
1243.7000--Environmental
1243.8000--Bioresearch Monitoring (BIMO)
- 1243.8220 Requesting a BIMO Status Check
August 14, 2020 - 1243.8225 Routing and Review of BIMO Establishment Inspection Reports (EIRs)
May 19, 2015