🐎Horse Protection Amendments
On May 8, 2024, we published a final rule amending the horse protection regulations. The amendments to the final rule initially scheduled to go into effect on February 1, 2025, were delayed until April 2, 2025. In this document, we are further delaying the effective date of the amendments effective April 2, 2025, to February 1, 2026. We are also seeking comment on whether the length of this postponement should be extended and soliciting any supplemental information that may help inform a decision regarding an appropriate length of postponement.
Learn More🧬FDA Guidance on Heritable Genomic Alterations in Animals
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry #187B entitled "Heritable Intentional Genomic Alterations in Animals: The Approval Process." This guidance clarifies FDA's requirements and recommendations for developers of intentional genomic alterations (IGAs) in animals. The guidance is one of two companion documents. "Heritable Intentional Genomic Alterations in Animals: The Approval Process" describes how the FDA approval process applies to heritable IGAs in animals. The companion final guidance, GFI #187A entitled "Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach," describes FDA's risk-based regulatory approach to the oversight of heritable IGAs in animals.
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