Drug Development Resources for Animal Drug Sponsors

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.

Getting Started with the Drug Approval Process

• How to Get a New Animal Drug Approved and First Steps to Get Started
• Resources and First Steps for Aquaculture New Animal Drug Sponsors

ADUFA V Animal Drug User Fee Educational Conference

CVM Public Meeting: First Annual Animal Drug User Fee Educational Conference

Recording and Transcript

• Morning Transcript
• Afternoon Transcript, Part 1
• Afternoon Transcript, Part 2

Event Materials

• Final Agenda
• Slides

Submitting Electronically

• Electronic Submissions page
• CVM eSubmitter Resource Center

Quick Links

Office of New Animal Product Evaluation Contact Information
Office of Generic Animal Drugs Contact Information

Requesting an Informal Written Response from CVM Office of New Animal Drug Evaluation through eSubmitter Questions and Answers

Approved Animal Drug Products (Green Book)

• Animal Drugs @ FDA
• Environmental Assessments and Finding of No Significant Impact (FONSI)
• Drug Labeling

ONADE Policy and Procedures (contains review processes and administrative information)

Public Master Files

• Minor Use & Minor Species
• Major Species

Compliance Information

• Program Guidance Manual
• Compliance Policy Guides

Animal Drug User Fee Act (ADUFA) & Animal Generic Drug User Fee Act (AGDUFA)

Animal Drug User Fee Act (ADUFA)

Animal Generic Drug User Fee Act (AGDUFA)

Guidance for Industry 170: Animal Drug User Fees and Fee Waivers and Reductions

Data Quality

Data Quality Resources

Pilot Program for Use of H Submissions to Propose Raw Data and Documents for Target Animal Safety Studies – Pilot Completed

• As of January 3, 2022, CVM is no longer accepting submissions for this pilot program. The pilot has ended, and CVM will be evaluating the feedback received during the program and the best path forward on the topic of communicating raw data submission recommendations to animal drug sponsors.

Minor Use and Minor Species (MUMS)

• eCFR :: 21 CFR Part 516 -- New Animal Drugs for Minor Use and Minor Species
• Minor Use/Minor Species
• Office of Minor Use and Minor Species
• OMUMS FAQs
• Drug Designation
• Drug Indexing
• Conditional Approval
• Public Master Files (PMFs) Supporting Applications for Minor Use and Minor Species Drugs
• Minor Use Animal Drug Program (MUADP)

Pioneer Drug Approval Process

ONAPE Project Managers- Our Role in the Animal Drug Approval Process

Food Animal Drug Review Process

• Phased Review Process
• Traditional Review Process - Please contact the ONADE Project Management Team at CVM.ONADE.PM@FDA.HHS.GOV
• ADAA Combo Review Process
• Free-Choice Review Process
  • Guidance for Industry 13 Evaluation of Effectiveness of New Animal Drugs for Use in Free-Choice Feeds-Medicated Block
  • Guidance for Industry 23 Medicated Free Choice Feeds--Manufacturing Control
• Aquaculture

Companion Animal Drug Review Process

• Phased Review Process
• Traditional Review Process - Please contact the ONADE Project Management Team at CVM.ONADE.PM@FDA.HHS.GOV

Conditional Approval

• Conditional Approval MUMS
• Expanded Conditional Approval

Supplemental

• B1 Supplements to an Approved ANADA, NADA, or for post-approval supplements - Please contact the ONADE Project Management Team at CVM.ONADE.PM@FDA.HHS.GOV

Animal Bioengineering and Cellular Therapies

• FDA’s Role in Veterinary Regenerative Medicine
• Intentional Genomic Alterations in Animals: Resources for Developers
• Veterinary Innovation Program (VIP)

Environmental Submissions for all Pioneer Approvals

• Environmental Impact Considerations

Generic Animal Drug Approval Process

Generic Animal Drug Review Process

• Phased Review Process
  • Abbreviated New Animal Drug Applications
  • Administrative Applications and the Phased Review Process
• Traditional Review Process

Innovations

• B1 Supplements to an Approved ANADA - Please contact the Division of Generic Animal Drugs at CVMDGADMGT@fda.hhs.gov
• Suitability Petitions

Generic Animal Drug and Patent Term Restoration Act (GADPTRA)

Environmental Impact Considerations

Chemistry, Manufacturing and Controls

CMC Guidance for Industry

Veterinary Master Files

• Common Questions Related to Type II Veterinary Master Files (VMFs)

Compilation of FDA Guidance and Resources for in vitro Dissolution Testing of Solid Oral Dosage Forms

Manufacturing Considerations for Penicillin or Cephalosporin Animal Drugs

Chemistry, Manufacturing, and Controls (CMC) Information Submitted to Both CDER and CVM

Submitting Establishment Information to the Animal Drug Manufacturing System (ADMS)

Split Tablet Studies

Labeling

Proposed Rule - Labeling Requirements for Approved or Conditionally Approved New Animal Drugs

Medicated Feed Labeling (Blue Bird)

• Guidance for Industry 181 Blue Bird Medicated Feed Labels

Distributor Labeling for New Animal Drugs

Structured Product Labeling (SPL)

Labeling Supplements

• NL
• NF
• Manufacturing

Regulatory Resources

Animal Drugs @ FDA

Veterinary Feed Directive

Import Tolerances

Public Master Files

• Minor Species
• Major Species

Aquaculture Drug Basics

Veterinary Innovation Program

Biotechnology

Electronic Code of Federal Regulations

CVM Guidance for Industry (GFIs)

CVM/ONADE Reviewer's Chapter

Federal Register

Compilation of FDA Guidance and Resources for in vitro Dissolution Testing of Immediate Release Solid Oral Dosage Forms

FDA and European Medicines Agency Parallel Scientific Advice Program for Animal Drugs

CVM FOI Summaries & How to Submit a FOIA Request

• Animal Drug FOI Summaries
• Instructions/Helpful Information
• Electronically Submit FOIA Request