October 14, 2019

October 14, 2019

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FDA Announces Plant and Animal Biotechnology Innovation Action Plan

In an October 30 press release, FDA announced their new Plant and Animal Biotechnology Innovation Action Plan in an effort to foster advances in the field as new technologies to edit animal and plant genomes have the potential to improve human and animal health, animal well-being, food productivity, and food security. For example, new forms of biotechnology allow for the modification of living organisms which may generate opportunities to improve public health, such as through the creation of novel pharmaceuticals, new food varieties, or disease-resistant crops.

The Action Plan provides an overview of FDA’s priorities to support innovation in plant and animal biotechnology and to advance the agency’s public health mission. Specifically, the Action Plan identifies priorities in three key areas:

  1. Advancing public health by promoting innovation

  2. Strengthening public outreach and communication

  3. Increasing engagement with domestic and international partners

In all, the priorities are intended to ensure the safety of plant and animal biotechnology products, foster continued public confidence in FDA’s regulation of these products, and avoid unnecessary barriers to future innovation consistent with FDA’s mission to protect and promote the public health. While many of the priorities outlined in the Action Plan are already underway, FDA intends to continue implementation of the commitments made under the Action Plan through 2020.

To begin implementation of the Action Plan, FDA will adopt a comprehensive policy framework for the development and regulatory oversight of animal biotechnology products in order to advance the Agency’s commitment to safety while stewarding innovation. FDA also intends to publish several guidance documents that will provide greater clarity on how FDA is applying its regulatory oversight to evaluate new biotechnology products. In addition to the Action Plan, FDA announced two upcoming programs:

  • A public webinar on December 3, 2018 on genome editing in animals which will focus on the current science, promising technology, and potential risks. Additionally, the webinar will provide information about the Center for Veterinary Medicine’s flexible, risk-based approach to the regulation of intentional genomic alterations in animals.

  • The Veterinary Innovation Program (VIP) is a new pilot program intended to facilitate advancements in the development of innovative animal products. The goal of VIP is to provide greater clarity and certainty in the regulatory process, encourage development and research, and support an efficient and predictable pathway towards approval for intentionally genetically altered animals (IGA animals) and animal cells, tissues, and cell- or tissue-based products (ACTPs).

FDA emphasized that the Action Plan is intended to help the agency ensure the safety of plant and animal biotechnology products while fostering innovation. FDA further stated their hopes for the Action Plan to produce a collaborative effort among all biotechnology stakeholders to promote efficient and clear regulatory pathways and to ensure safe products enter the marketplace.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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