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  1. Biotechnology Products at CVM: Animals and Animal Food

Center for Veterinary Medicine (CVM) Animal Biotechnology Products Resource Center

Welcome to the Animal Biotechnology Products Resource Center. Animal biotechnology is a rapidly growing area of product development and includes products such as intentional genomic alterations (IGAs) in animals and animal cells, tissues, and cell- and tissue-based products (ACTPs). 

CVM is committed to engaging with industry, academia, animal owners/producers, and other stakeholders to increase the transparency of our regulatory process. This page aims to assist developers of animal biotechnology products with navigating the regulatory process.

Animal Biotechnology Info Rounds

The “Animal Biotechnology Info Rounds” documents each provide information on a different topic to assist sponsors in administrative procedures and interactions with CVM’s Division of Animal Bioengineering and Cellular Therapies (DABCT). 

Document Title Help Text
AR1: General Resources General Information and resources to help sponsors navigate the approval process.
AR2: Product Inquiries An overview of regulatory oversight determinations and how they are made.
AR3: CVM eSubmitter How to select the document type, submission type, and submission classification code.
AR4: Veterinary Innovation Program (VIP) A description of the VIP and its associated benefits.
AR5: Opening a File A summary of the information submitted to support opening a VMF or an INAD file.
AR6: Requesting a Meeting How to request the three most common meeting types.
AR7: Collaborations between FDA Centers A description of the collaboration of multiple FDA Centers for related approvals.

Animal Biotechnology Webinars

The Animal Biotechnology Webinars are series of informational webinars and stakeholder outreach sessions that assist developers of animal biotechnology products navigate regulatory processes, understand guidance documents and principles, and provide insight into our current regulatory thinking on multiple areas.

Document Title Help Text
CVM Public Webinar: Genome Editing in Animals

(April 2019)
This webinar focused on CVM’s flexible, risk-based approach to regulation of IGAs in animals and addressed common questions associated with FDA oversight.
FDA CVM Animal Biotechnology Webinar for Developers

(September 2020)
The webinar describes the hypothetical products and provides information on CVM’s oversight process.
Animal Biotechnology Stakeholder Virtual Outreach Session

(May 2021)
At the session, CVM collected feedback from stakeholders in order to enhance the predictability, transparency, and efficiency of the review process for IGAs in animals.
FDA CVM Public Webinar on the Development of ACTPs

(October 2021)
In this three-part webinar, CVM provided information and examples on current good manufacturing practices for ACTPs related to preserving cellular function and integrity, ensuring consistency of the process and product, preventing contamination, selecting appropriate donors and preventing transmission of disease.
FDA Animal Biotechnology Webinar Case Study for a Low-Risk Intentional Genomic Alteration in Animals for Food Use

(June 2022)
This webinar provides an overview of the agency’s risk-based review process for Intentional Genomic Alterations (IGAs) in animals that may pose low risk and discusses the agency’s recent review of genome-edited beef cattle as a case study.
FDA Animal Biotechnology Case Study Webinar for Investigational Food Use Authorizations of Animals with Investigational Intentional Genomic Alterations

(May 2023)
This webinar provides an overview of the process of requesting an Investigational Food Use Authorization (IFUA) for animals with investigational intentional genomic alterations (IGAs) and discusses case study examples that cover different types of scenarios where developers of IGAs in animals might request IFUAs.
FDA Animal Biotechnology Webinar: Bioinformatics Review of Next Generation Sequencing Data

(March 2024)
This webinar provides an overview of FDA’s bioinformatics review of next generation sequencing (NGS) data in support of the molecular characterization of intentional genomic alterations (IGAs) in animals and the process for electronically submitting NGS data using precisionFDA

Questions?

If you have any questions about the information on this page, please use the contact information below.

  • For questions about animal biotech, contact us at AskCVM-Biotech@fda.hhs.gov
  • For general questions about the approval process, contact the ONADE Project Management team at CVM_PM_Biotech@fda.hhs.gov.
  • For specific questions about eSubmitter, contact the eSubmitter help desk at cvmesubmitter@fda.hhs.gov.
  • The information presented here is intended only for developers of animal biotechnology products. For information on other product types or for all other general inquiries, contact AskCVM@fda.hhs.gov

 



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