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).
This page aims to assist sponsors of animal biotechnology products with navigating the approval process. 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).
If you have any questions about the information on this page, please use the contact information below.
- 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 email@example.com.
- The information presented here is intended only for sponsors of animal biotechnology products. For information on other product types or for all other general inquiries, contact AskCVM@fda.hhs.gov.
|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.|