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How to Regulate Genome Edited Animals? A Comment on FDA’s Proposed Guidance Open Access

The George Washington University Regulatory Studies Center improves regulatory policy through research, education, and outreach. As part of its mission, the Center conducts careful and independent analyses to assess regulatory proposals from the perspective of the public interest. This comment on the Food and Drug Administration’s draft guidance does not represent the views of any particular affected party or special interest, but is designed to evaluate the effect of FDA’s draft on overall consumer welfare. The FDA has proposed an approach to oversight of genome edited animals that closely follows its current policy regarding genetically engineered animals.

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