1243.2000--ONAPE's and OGAD's General Review 1243.2010 Responsibilities for Keeping and Maintaining Records 1243.2020 United States (U.S.)-Based Employee and U.S. Agent Representation of Foreign Sponsors 1243.2030 Responding to Requests for Copies of Individual Official Communications or Administrative Document Files 1243.2050 Refuse to File and Refuse to Review 1243.2100 Eligibility for Conditional Approval Under the Expanded Conditional Approval (XCA) Criteria 1243.2180 Certifications for New Animal Drug Submissions and Applications 1243.2200 Submission and Review of Early Information (EI) to Presubmission Conferences and Protocol Review 1243.2341 Transfer of Ownership 1243.2342 Change of Sponsor Name or Address 1243.2400 Veterinary Master Files with Manufacturing Information 1243.2600 Review of ONADE-Regulated Products that Contain Nanomaterials or Otherwise Involve the Use of Nanotechnology 1243.3000--Admin Procedures for ONAPE and OGAD 1243.3002 Handling and Rejecting Paper Applications and Submissions 1243.3005 Creating Clean Electronic Files 1243.3009 Format and Style Conventions for Reviews and Submission Summaries 1243.3010 Format and Style Conventions for Letters 1243.3011 Voiding Submissions and Discontinuing the Review of Pending Submissions and Applications 1243.3013 Receiving and Responding to Informal Communication Requests Through eSubmitter 1243.3015 Proprietary Names 1243.3020 Review of Submissions in the STARS Queue 1243.3021 Portfolio Overview Meetings with Sponsors of New Animal Drug Application Projects 1243.3023 Lessons Learned Meetings for New Animal Drug Application Projects 1243.3024 Scheduling and Holding Meetings with Outside Parties 1243.3025 Preparing Meeting Documentation (i.e., Early Response Letter, Memorandum of Conference, Acknowledgement Letter, Other Review Documentation) 1243.3026 Assessing Submission Quality and Amending and Resetting the Clock on Submissions 1243.3028 Administrative Pathways for Obtaining Additional Chemistry, Manufacturing, and Controls Information 1243.3029 Closing Out Consulting Reviews for Submission Tracking and Reporting System (STARS) Submissions 1243.3030 Completing Final Action Packages for Submission Tracking and Reporting System (STARS) Submissions 1243.3040 Processing Suitability Petitions 1243.3050 Determining Technical Section Requirements for New Animal Drug Product Approval 1243.3051 Verifying Scope and Technical Section Status for Phased Review Projects in the End Game 1243.3060 Implementing Shortened Review Times for New Animal Drug Application (NADA) Reactivations and Investigational New Animal Drug (INAD) File Resubmissions Using eSubmitter 1243.3070 Implementing Shortened Review Times for Abbreviated New Animal Drug Applications (ANADA) Reactivations and Generic Investigational New Animal Drug (JINAD) Resubmission 1243.3200 Routing a Request to Obtain a Consulting Review of a Submission Tracking and Reporting System (STARS) Submission 1243.3210 Requesting a Quality Control Review from the Quality Assurance Team for Final Action Packages Signed by the Office or Center Director 1243.3215 Requesting a Quality Assurance Study Review from the Quality Assurance Team 1243.3250 Q Submissions: Agency-Initiated Actions 1243.3750 Sponsor Requests to Reserve An Application Number for a New Animal Drug or Abbreviated New Animal Drug Application 1243.3760 Drug Tolerance Notification Process 1243.3800 Reviewing, Preparing, and Routing Approval Packages for Certain Abbreviated and New Animal Drug Applications 1243.3801 Completing the Green Book and Animal Drugs @ FDA (GBAAD) Form 1243.3810 Creating and Maintaining a Reference Copy of the Currently Approved Labeling for an Application (Volume 0) 1243.3900 Updating the Animal Drugs @ FDA Website and Green Book 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 1243.4040 Investigational Food-Use Authorizations: The Role of the Target Animal Division Reviewer 1243.4041 Investigational Food-Use Authorizations: The Role of Division of Human Food Safety Reviewer 1243.4060 Review of Protocols 1243.4065 Requirements For Investigational New Animal Drug Exemptions 1243.4066 Notice of Claimed Investigational Exemption (NCIE) 1243.4068 Acceptability of Submissions Containing Foreign Data to Support Safety and Effectiveness 1243.4069 Review of Target Animal Safety or Effectiveness Data (P) Submissions 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 1243.4071 Review of Raw Data for Bioequivalence Studies to Support an Abbreviated New Animal Drug Application 1243.4075 Post-Bioequivalence Technical Section (Post-BETS) Meetings 1243.4080 Labeling and All Other Information Technical Sections (Minor Technical Section or M Submissions) 1243.4085 All Other Information 1243.4090 Processing a Sponsor Request for Written Feedback Regarding Development Plans (INAD C Submission) for New Animal Drug Product Approvals 1243.4092 H Submissions Preceding Meetings and Protocols 1243.4095 Review of Raw Data Agreement H Submission for Target Animal Safety and Effectiveness Studies 1243.4096 Review of Raw Data for Marker Residue Depletion Studies to Support a New Animal Drug Application 1243.4097 ONAPE Electronic Data Capture (EDC) Remote Access Review Program 1243.5000--New Animal Drug Applications (NADA) 1243.5704 Process for Eligible Sponsors to Obtain Conditional Approval 1243.5706 Meeting to Discuss Post-Approval Responsibilities for Sponsors of Conditional Approvals 1243.5708 Procedure for Sponsors to Maintain Conditionally Approved Products and Obtain Full Approval 1243.5725 Final Printed Labeling and Electronic Printed Labeling 1243.5730 Review of 60-Day Animal Drug Availability Act of 1996 (ADAA) Feed Use Combination New Animal Drug Applications (NADAs) 1243.5740 ANADA Memorandum Recommending Approval 1243.5741 Memorandum Recommending Approval (MRA) for Original and Supplemental (Abbreviated) New Animal Drug Applications ((A)NADA) 1243.5760 Process for Preparing an Executive Summary for a Freedom of Information Summary 1243.5761 Freedom of Information (FOI) Summary for Original and Supplemental New Animal Drug Applications (NADA) 1243.5762 Freedom of Information (FOI) Summary for an ADAA Medicated Feed Combination New Animal Drug Application 1243.5763 Process for Correcting Published Freedom of Information (FOI) Summaries 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 1243.5820 Approval Letters 1243.6000--Supplemental NADAs 1243.7000--Environmental 1243.8000--Bioresearch Monitoring (BIMO) 1243.8500--Chemistry Review
Content current as of:
09/28/2026
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