Drug Development Resources for Animal Drug Sponsors
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
Compliance Information
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.
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
- 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
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
Generic Animal Drug Review Process
- 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)