From listmaster animalgenome.org Wed Apr 3 14:20:12 2019
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From: "Matukumalli, Lakshmi - NIFA" <lmatukumallinifa.usda.gov>
Postmaster: submission approved by list moderator
To: Members of AnGenMap <angenmapanimalgenome.org>
Subject: FDA's Animal Biotechnology Innovation Plan
Date: Wed, 03 Apr 2019 14:20:12 -0500
FYI ...
FDA Advancing Beneficial Animal Biotechnology Product Development (Latest
FDA Press Release)
https://www.fda.gov/...634432.htm
Last October, the FDA announced its Plant and Animal Biotechnology
Innovation Action Plan, which focuses on the agency's risk-based regulatory
framework. This framework will help secure confidence in the safety and
performance of plant and animal-based innovative products for consumers,
patients, and America's global trading partners. Making sure these products
are safe and perform as expected is critical to maintaining consumer and
commercial confidence in them and realizing their potential benefits for
human and animal health.
CVM Public Webinar: Genome Editing in Animals
https://www.fda.gov/...s/ucm62421
6.htm On April 25, 2019, the U.S. Food and Drug Administration's
Center for Veterinary Medicine (CVM), with participation from the agency'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. The webinar will
focus primarily on the current scientific evidence, promising uses of this
technology in animals, and the potential risks. The webinar will also
provide information about CVM's flexible, risk-based approach to the
regulation of intentional genomic alterations (IGAs) in animals, including
alterations made with genome editing, and how, if needed, to navigate FDA
approval requirements for IGAs that are products of this technology. It
will also seek to address common questions associated with FDA oversight.
The final portion of the webinar will be dedicated to answering
stakeholder-submitted questions. This webinar will not cover genome editing
of plants for use in human and/or animal food. Date April 25, 2019,
1:00 pm - 3:00 pm ET Registration Advance registration is required to
participate in the live-cast webinar. To register, please visit
https://collaboration.fda.gov/..._info.html
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Lakshmi Kumar
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