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FDA Announces Plant and Animal Biotechnology Innovation Action Plan

On April 25, 2019, the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM), with participation from the FDA’s Center for Biologics Evaluation and Research (CBER), will hold a public webinar about genome editing in animals, an innovative and rapidly evolving technology that offers significant public health benefits. This webinar is rescheduled from the original date of December 3, 2018. For more information, please see “CVM Public Webinar: Genome Editing in Animals.”

October 30, 2018

Today, the U.S. Food and Drug Administration announced the Plant and Animal Biotechnology Innovation Action Plan to outline the key priorities the agency will pursue to support innovation in plant and animal biotechnology while advancing the agency’s public health mission. The overall goal of the action plan is to ensure the safety of plant and animal products of biotechnology while avoiding unnecessary barriers to future innovation.

Key next steps from the action plan include:

Veterinary Innovation Program (VIP)

The FDA’s Center for Veterinary Medicine (CVM) is launching a pilot of this program today to offer intensive technical and programmatic assistance to developers of certain innovative veterinary products, including animal biotechnology products. VIP includes a set of tools to guide sponsors through the regulatory process, options to develop alternative strategies for generating necessary evidence, pre-submission reviews of data packages, and cross-disciplinary and coordinated FDA review.

The FDA intends VIP to enhance regulatory predictability and efficiency, improve agency responsiveness, and enable early, sustained interactions with innovators. Learn more by visiting: VIP: Veterinary Innovation Program.

CVM Genome Editing in Animals Public Webinar

CVM, along with representatives from FDA’s Center for Biologics Evaluation and Research (CBER), will host a live-cast webinar on April 25, 2019 (rescheduled from Dec. 3, 2018) to discuss FDA’s flexible, risk-based regulatory approach and current scientific evidence and regulatory science questions that are important for the agency’s decision-making for genome editing in animals.

This webinar is an initial step in FDA’s public communication strategy to help innovators understand how FDA regulatory oversight applies to their products and support safe and responsible innovation for public health.

Advance registration is required: Webinar Registration. When registering, stakeholders are encouraged to submit questions for FDA to address during the webinar. A recording will be posted to the website shortly following the live cast.

Guidance Documents

Animal Biotechnology

The FDA is committed to adopting and clarifying a comprehensive policy framework for the development and oversight of animal biotechnology products, including for drug and food products derived from intentionally genetically altered animals.

In the coming year, the FDA intends to issue several guidance documents in the area of animal biotechnology. Among these documents will be highly anticipated guidance for industry that clarifies FDA’s regulatory approach using risk-based categories for regulatory oversight, gives clear criteria and risk questions or data requirements where relevant for each risk-based category, and provides flexibility to move across categories as science and technology progress and FDA gains greater understanding with product risk profiles.

Plant Biotechnology for Human and Animal Food Use

After reviewing information submitted to the 2017 request for comment on the use of genome editing techniques to produce new plant varieties for use in human or animal food, the FDA intends to publish draft guidance for industry to explain FDA’s current regulatory policy for human and animal foods produced through modern molecular plant breeding techniques.

Continued Collaboration with Stakeholders

As part of efforts to engage with domestic and international partners, the FDA will coordinate with the U.S. Environmental Protection Agency and the U.S. Department of Agriculture as the agency clarifies its oversight of genome edited products, consistent with the U.S. Coordinated Framework for the Regulation of Biotechnology. The FDA will also support international regulatory alignment on risk-based genome editing policies and provide leadership in international forums.

In addition, the FDA will work with domestic and international partners and engage in a dialogue about how transformative biotechnology tools, such as gene drives, may eventually strengthen measures to address vector-borne diseases.

Additional Information

Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.

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