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
Chemistry, Manufacturing and Controls
Compliance Information
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
- Veterinary Regenerative Medicine & Animal Cell-Based Products
- Animals with Intentional Genomic Alterations
- 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)