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  1. Animals with Intentional Genomic Alterations

VIP: Veterinary Innovation Program

for Certain New Animal Drug Applications for Intentional Genomic Alterations in Animals and Animal Cell, Tissues, and Cell- or Tissue-Based Products

What is the VIP?

The FDA Center for Veterinary Medicine’s (CVM) Veterinary Innovation Program (VIP) is for certain intentional genomic alterations (IGA) in animals and animal cells, tissues, and cell- or tissue-based products (ACTPs) seeking FDA approval of a new animal drug application (NADA). The goal of the VIP is to facilitate advancements in development of innovative animal products by providing greater certainty in the regulatory process, encouraging development and research, and supporting an efficient and predictable pathway to approval for ACTPs and IGAs in animals.

The VIP offers benefits including extensive interactions between CVM and the sponsor (you). These interactions can increase the predictability of the regulatory pathway, facilitate a lower number of review cycles, and reduce the overall time to approval. Continuing interactions and collaboration with CVM throughout the approval process maximizes the ability to address potential challenges in product development, leverage data from multiple sources, minimize the number of studies conducted to support approval, enhance communication in the review process, and maintain an understanding of current scientific and regulatory advancements.

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Who Can Participate in the VIP?

Double-stranded DNA complexed with Cas9, an RNA-guided DNA endonuclease enzyme associated with the CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) adaptive immunity system in certain bacteria. An RNA template has guided the Cas9 nuclease to the DNA target site where it has made a double stranded cut for subsequent DNA repair.

Sponsors of IGAs in animals or ACTPs that provide a benefit to human health, animal health, animal well-being (e.g. husbandry improvements), or enhanced food production may participate in the VIP. For purposes of this program, an IGA in an animal is an intentional alteration to an animal's DNA that has been made using modern molecular technologies and an ACTP is one that contains, consists of, or is derived from cells or tissues that are intended for implantation, transplantation, infusion, or transfer into an animal recipient. If you are unsure if your product is an IGA or ACTP over which FDA has jurisdiction, contact us at [email protected].

Submission quality is critical to achieving efficiency in the approval process. The VIP includes benefits intended to ensure you have the necessary tools to generate quality submissions.

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How will I know if my product can be in the VIP?

We recommend you contact CVM as early as possible in the development process if you are interested in participating in the VIP for your product.

Your ACTP or IGA qualifies for the VIP if you have not heard from us in writing that it does not qualify within 30 days of your initial request to establish an investigational new animal drug file (INAD) or veterinary master file (VMF) (contact CVM about which type of file is appropriate for your product). If you receive written notice that your product does not qualify for the VIP, and you believe that it qualifies, you should contact CVM and discuss what additional information you should provide that will explain how your product is either an ACTP or an IGA in an animal that provides a benefit to human health, animal health, animal well-being (e.g. husbandry improvements), or food production. CVM will review the information in your INAD or VMF relating to the product description, proposed claim or indication, and mechanism of action in determining whether the product qualifies for the VIP.

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What are the Benefits of the VIP?

The VIP provides intensive assistance and enhanced review efficiency for developers of ACTPs and IGAs in animals.

Under the Veterinary Innovation Program (VIP), sponsors begin by requesting that the Center for Veterinary Medicine (CVM) find their product eligible for the program. CVM will assess the eligibility request and if it determines that the product is not eligible, it will notify the sponsor within 30 days of the request. Otherwise, the sponsor should assume that it’s product is eligible. At that point, the sponsor may open either a Veterinary Master File (VMF) for products that are in pre-investigational development (PID), or they may open an investigational new animal drug file (INAD) if they are farther along in their product development process. For products in PID, the benefits of the VIP program at that stage include discussion of regulatory challenges, pre-INAD meetings, intensive interactions, and exchange of information with CVM. Once a product is farther along in its development process, the sponsor opens an INAD. Early in the INAD development process, the benefits of the VIP include formation of a review team, senior management involvement, frequent interaction with the review team, discussion of alternative data options, and a first pre-submission conference. After this early INAD INAD phase, the sponsor begins to submit technical sections of its application. Benefits of the VIP program at this stage include, senior management involvement, frequent interactions with the review team, pre-submission conferences, “how-to” help for post-approval requirements, pre- and post-review feedback, stopping the review clock to allow time to correct deficient submissions, alternative data options, and feedback on assay development. Once the technical section submission phase is complete, the sponsor requests approval of the new animal drug application for the product.

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Can my product’s qualification for the VIP be withdrawn?

In the event that you repeatedly submit poor quality submissions for a product despite assistance received through the VIP, we may elect to withdraw your product’s qualification for this program. Similarly, your product may not be eligible for certain VIP benefits in some circumstances. For example, stopping the review clock is intended to address scientific issues related to review of novel products. It is not intended to rehabilitate poor quality submissions. A submission is only eligible to stop the review clock if the submission quality is acceptable.

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