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Resources for You

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                        CVM en español
          Animal Health Literacy Home
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          Drug Development Resources for Animal Drug SponsorsResources for You Drug Development Resources for Animal Drug Sponsors
  
  	
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    PrintGetting 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

Submitting Electronically
	Electronic Submissions page
	CVM eSubmitter Resource Center

Quick Links
	**ONADE Organizational Directory**

**Approved Animal Drug Products (Green Book)**

Animal Drugs @ FDA
	FOI Information
	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.

Pioneer Drug Approval Process
	**ONADE 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
	**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

MUMS Designation

Public Master Files

Minor Species
	Major SpeciesAquaculture 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

                                                                                  Content current as of:
      10/13/2023Resources for You

          
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