Animal & Veterinary

CVM/Office of New Animal Drug Evaluation (ONADE) Reviewer's Chapter

       

1243.2000--ONADE's General Review

TitleDate
1243.2010 Responsibilities for Creating and Keeping Records (PDF - 574KB) July 2, 2003
1243.2030 Responding to Requests for Copies of Letters or Requests for Copies of Administrative Files (PDF - 154KB) August 21, 2013
1243.2050 Refuse to File and Refuse to Review (PDF - 317KB) August 14, 2017
1243.2180 New Animal Drug Applications Certifications (PDF - 228KB) July 30, 2015
1243.2200 Submission and Review of Early Information (EI) Prior to Presubmission Conferences and Protocol Review (PDF - 487KB) August 25, 2016
1243.2340 Transfer of Ownership and Sponsor Name or Address Change Procedures in ONADE for NADA, ANADA, INAD, JINAD or VMF Submissions (PDF - 237KB) Nov. 16, 2001
1243.2600 Review of ONADE Regulated Products that Contain Nanomaterials or Otherwise Involve the Use of Nanotechnolgy (PDF - 395KB) July 22, 2016

1243.3000--Admin Procedures for ONADE

TitleDate
1243.3005 Creating Clean Electronic Files (PDF - 245KB) June 13, 2016
1243.3009 Format and Style Conventions for Reviews and Submission Summaries (PDF - 420KB) June 21, 2016
1243.3010 Format and Style Conventions for Letters (PDF - 426KB) June 13, 2016
1243.3015 Proprietary Names (PDF - 285KB) June 15, 2016
1243.3020 Managing the Review of Submissions in the STARS Queue (PDF - 68KB) Jan. 26, 2009
1243.3022 Implementing the User Fee Acts (ADUFA III, AGDUFA II) of 2013 (PDF - 245KB) May 2, 2017
1243.3024 Scheduling and Holding Meetings With Outside Parties (PDF - 83KB) Sept. 6, 2016
1243.3025 Preparing a Memorandum of Conference (MOC) (PDF - 443KB) July 8, 2016
1243.3026 Amending STARS Submissions (PDF - 249KB) June 18, 2010
1243.3029 Closing Out a Consulting Review for STARS Submissions (PDF - 218KB) July 8, 2016
1243.3030 Completing Final Action Packages for STARS Submissions (PDF - 123KB) May 17, 2017
1243.3040 Processing Suitability Petitions (PDF - 232KB) May 11, 2016
1243.3050 Identifying and Documenting Technical Section Requirements for Approval (PDF - 139KB) June 9, 2011
1243.3051 Verifying Scope and Technical Section Status for Phased Review ([J]INAD) Projects in the End Game (PDF - 216KB) June 13, 2016
1243.3200 Routing a Request to Obtain a Review of an INAD, JINAD, ANADA, NADA, or VMF Submission (PDF - 383KB) July 5, 2016
1243.3210 Requesting a QC Consult from the Quality Assurance Team (PDF - 190KB) July 22, 2016
1243.3250 "Q" Submissions: Agency-Initiated Actions (PDF - 276KB) June 15, 2016
1243.3300 FDA District Office Mail Codes (PDF - 100KB) April 11, 2017
1243.3750 Sponsor Requests to Reserve an (A)NADA Number (PDF - 153KB) June 23, 2016
1243.3760 Drug Tolerance Notification Process (PDF - 344KB) July 14, 2017
1243.3800 Reviewing an (A)NADA and Preparing an Approval Package (PDF - 134KB) August 29, 2017
1243.3810 Creating and Maintaining a Reference Copy of the Currently Approved Labeling for an Application (Volume 0) (PDF - 322KB) July 8, 2016
1243.3900 Updating the Animal Drugs at FDA Website and Green Book (PDF - 105KB) June 30, 2017

TitleDate
1243.4000 Processing a Request to Open a (J)INAD File (PDF - 89KB) August 30, 2017
1243.4040 Investigational Food-use Authorizations: the role of the primary (AA) review divisions (PDF - 722KB) Oct. 5, 2016
1243.4041 Investigational Food-use Authorizations: the role of Division of Human Food Safety reviewer (PDF - 305KB) June 15, 2016
1243.4060 Review of Protocols (PDF - 375KB) July 1, 2016
1243.4065 Requirements For Investigational New Animal Drug Exemptions (PDF - 91KB) July 11, 2017
1243.4066 Notice of Claimed Investigational Exemption (NCIE) (PDF - 188KB) July 18, 2017
1243.4068 Acceptability of Submissions Containing Foreign Data to Support Safety and Effectiveness (PDF - 59KB) Jan. 26, 2009
1243.4080 Labeling and All Other Information Technical Sections (Minor Technical Section or "M" Submissions) (PDF - 450KB) June 17, 2016
1243.4085 All Other Information (PDF - 148KB) April 12, 2012
1243.4089 Process for Evaluating Joint Expert Committee on Food Additives (JECFA) and Joint Meeting on Pesticide Residues (JMPR) Monographs and Reports to Support Human Food Safety and Human User Safety (PDF - 63KB) September 18, 2017

1243.5000--New Animal Drug Applications (NADA)

TitleDate
1243.5740 ANADA Memorandum Recommending Approval (PDF - 253KB) Nov. 16, 2001
1243.5741 Memorandum Recommending Approval (MRA) for Original and Supplemental New Animal Drug Applications (NADA (PDF - 101KB) Dec. 13, 2007
1243.5761 Freedom of Information Summary for Original and Supplemental NADA (PDF - 464KB) July 3, 2017
1243.5762 Freedom of Information Summary for an ADAA Feed Combination NADA Approval (PDF - 349KB) Dec. 4, 2008
1243.5763 Procedure for Correcting Published Freedom of Information (FOI) Summaries (PDF - 905KB) May 10, 2016
1243.5780 Exclusivity and Exclusive Marketing Rights Boilerplate Language for Use in the Following Documents: Memorandum Recommending Approval, Letter to Applicant, and FOI Summary (PDF - 441KB) April 7, 2015
1243.5820 Approval Letters (PDF - 174KB) August 31, 2011

1243.6000--Supplemental NADAs

TitleDate
1243.6020 Review of NADA and ANADA Labeling Supplements (PDF - 323KB) June 22, 2016
1243.6030 Review of Labeling Changes in Manufacturing Supplements (PDF - 368KB) June 22, 2016
1243.6040 Review of (A)NADA 60-day NF Qualifying Labeling Supplements (PDF - 169KB) December 1, 2015

1243.7000--Environmental

TitleDate
1243.7220 Processing Environmental Impact Submissions for New Animal Drugs (PDF - 128KB) Aug. 30, 2010

1243.8000--Bioresearch Monitoring (BIMO)

TitleDate
1243.8215 Requesting a Bioresearch Monitoring (BIMO) Inspection (PDF - 117KB) April 11, 2017
1243.8220 Requesting a BIMO Status Check (PDF - 95KB) March 1, 2010
1243.8225 Routing and Review of BIMO Establishment Inspection Reports (EIRs) (PDF - 173KB) May 19, 2015

1243.8500--Chemistry Review

TitleDate
1243.8500 Making a Request for a (cGMP) Status for Approval Package (PDF - 85KB) February 14, 2017

Page Last Updated: 09/19/2017
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