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 - 187KB) July 2, 2003
1243.2030 Responding to Requests for Copies of Letters or Requests for Copies of Administrative Files (PDF - 87KB) August 21, 2013
1243.2050 Refuse to File and Refuse to Review (PDF - 55KB) April 26, 2010
1243.2180 New Animal Drug Applications Certifications (PDF - 87KB) July 30, 2015
1243.2200 Submission and Review of Early Information (EI) Prior to Presubmission Conferences and Protocol Review (PDF - 401KB) May 12, 2015
1243.2340 Transfer of Ownership and Sponsor Name or Address Change Procedures in ONADE for NADA, ANADA, INAD, JINAD or VMF Submissions (PDF - 116KB) Nov. 16, 2001
1243.2600 Review of ONADE Regulated Products that Contain Nanomaterials or Otherwise Involve the Use of Nanotechnolgy (PDF - 148KB) August 30, 2011

1243.3000--Admin Procedures for ONADE

TitleDate
1243.3005 Creating Clean Electronic Files (PDF - 105KB) Jan. 26, 2009
1243.3009 Format and Style Conventions for Reviews and Submission Summaries (PDF - 151KB) Oct. 14, 2011
1243.3010 Format and Style Conventions for Letters (PDF - 148KB) Oct. 14, 2011
1243.3015 Proprietary Names (PDF - 117KB) April 9, 2013
1243.3020 Managing the Review of Submissions in the STARS Queue (PDF - 36KB) Jan. 26, 2009
1243.3022 Implementing the User Fee Acts (ADUFA III, AGDUFA II) of 2013 (PDF - 284KB) April 4, 2014
1243.3024 Scheduling and Holding Meetings With Outside Parties (PDF - 182KB) May 23, 2012
1243.3025 Preparing a Memorandum of Conference (MOC) (PDF - 255KB) May 11, 2012
1243.3026 Amending STARS Submissions (PDF - 98KB) June 18, 2010
1243.3029 Closing Out a Consulting Review for STARS Submissions (PDF - 63KB) June 18, 2010
1243.3030 Completing Final Action Packages for STARS Submissions (PDF - 147KB) April 6, 2009
1243.3040 Processing Suitability Petitions (PDF - 196KB) Sept. 11, 2002
1243.3050 Identifying and Documenting Technical Section Requirements for Approval (PDF - 68KB) June 9, 2011
1243.3051 Verifying Scope and Technical Section Status for Phased Review ([J]INAD) Projects in the End Game (PDF - 40KB) June 9, 2011
1243.3200 Routing a Request to Obtain a Review of an INAD, JINAD, ANADA, NADA, or VMF Submission (PDF - 55KB) Nov. 10, 2009
1243.3250 "Q" Submissions: Agency-Initiated Actions (PDF - 44KB) July 26, 2011
1243.3300 FDA District Office Mail Codes (PDF - 69KB) Feb. 20, 2009
1243.3810 Creating and Maintaining a Reference Copy of the Currently Approved Labeling for an Application (Volume 0) (PDF - 79KB) March 1, 2012
1243.3900 Maintaining the Animaldrugs&fda.gov Database and Website (PDF - 60KB) Oct. 5, 2010

1243.4000--Investigational New Animal Drugs (INAD)

TitleDate
1243.4000 Processing a Request to Open a (J)INAD File (PDF - 38KB) December 7, 2011
1243.4040 Investigational Food-use Authorizations: the role of the primary (AA) review divisions (PDF - 167KB) July 7, 2009
1243.4041 Investigational Food-use Authorizations: the role of Division of Human Food Safety reviewer (PDF - 55KB) April 7, 2009
1243.4060 Review of Protocols (PDF - 176KB) April 26, 2010
1243.4065 Requirements For Investigational New Animal Drug Exemptions (PDF - 174KB) July 1, 2014
1243.4066 Notice of Claimed Investigational Exemption (NCIE) (PDF - 130KB) October 9, 2014
1243.4068 Acceptability of Submissions Containing Foreign Data to Support Safety and Effectiveness (PDF - 24KB) Jan. 26, 2009
1243.4080 Labeling and All Other Information Technical Sections (Minor Technical Section or "M" Submissions) (PDF - 63KB) April 12, 2012
1243.4085 All Other Information (PDF - 40KB) April 12, 2012

1243.5000--New Animal Drug Applications (NADA)

TitleDate
1243.5740 ANADA Memorandum Recommending Approval (PDF - 135KB) Nov. 16, 2001
1243.5741 Memorandum Recommending Approval (MRA) for Original and Supplemental New Animal Drug Applications (NADA (PDF - 28KB) Dec. 13, 2007
1243.5761 Freedom of Information Summary for Original and Supplemental NADA (PDF - 153KB) March 1, 2012
1243.5762 Freedom of Information Summary for an ADAA Feed Combination NADA Approval (PDF - 150KB) Dec. 4, 2008
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 - 188KB) April 7, 2015
1243.5820 Approval Letters (PDF - 60KB) August 31, 2011

1243.6000--Supplemental NADAs

TitleDate
1243.6020 Review of NADA and ANADA Labeling Supplements (PDF - 120KB) Nov. 10, 2009
1243.6030 Review of Labeling Changes in Manufacturing Supplements (PDF - 97KB) June 17, 2009
1243.6040 Review of (A)NADA 60-day NF Qualifying Labeling Supplements (PDF - 176KB) October 1, 2014

1243.7000--Environmental

TitleDate
1243.7220 Processing Environmental Impact Submissions for New Animal Drugs (PDF - 48KB) Aug. 30, 2010

1243.8000--Bioresearch Monitoring (BIMO)

TitleDate
1243.8215 Requesting a Bioresearch Monitoring (BIMO) Inspection (PDF - 59KB) March 1, 2010
1243.8220 Requesting a BIMO Status Check (PDF - 53KB) March 1, 2010
1243.8225 Routing and Review of BIMO Establishment Inspection Reports (EIRs) (PDF - 94KB) May 19, 2015

1243.8500--Chemistry Review

TitleDate
1243.8500 Making a Request for a (cGMP) Status for Approval Package (PDF - 60KB) July 14, 2009

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