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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  1. Resources for You

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.

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.

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

Food Animal Drug Review Process

Companion Animal Drug Review Process

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

Environmental Submissions for all Pioneer Approvals

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