Live Breaking News & Updates on Intentional genomic alterations

Biotech Stocks Facing FDA Decision In June 2024

THOUSAND OAKS (dpa-AFX) - Every year, the month of June is observed as the Alzheimer's and Brain Awareness Month, a time dedicated to raising awareness and fostering conversations about Alzheimer's

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Federal Agencies Issue Regulations for Products of Biotechnology

Federal Agencies Issue Regulations for Products of Biotechnology
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FDA Clarifies Approach to Genomic Alterations in Animals - Oskaloosa News

FDA Clarifies Approach to Genomic Alterations in Animals - Oskaloosa News
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Document solidifies FDA authority over genomically altered animals, with new input from USDA

Documents released Wednesday by FDA clarifies the agency will continue to lead the regulatory review of intentional genomic alterations in animals, with information-sharing from the Agriculture Department on some products. The agency also released updated guidance for the industry on the risk-based approach and approval process of these products.

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FDA updates approach to regulating genomic alterations in animals

Agency established a MOU with USDA to clarify roles and responsibilities.

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CVM GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process

This document explains how FDA’s approval process applies to heritable intentional genomic alterations in animals.

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FDA Clarifies Approach to Genomic Alterations in Animals

/PRNewswire/ -- Today, the U.S. Food and Drug Administration took important steps to advance the FDA s regulatory process for intentional genomic alterations...

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FDA Clarifies Approach to Genomic Alterations in Animals

FDA Clarifies Approach to Genomic Alterations in Animals
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FDA updates approach to regulating genomic alterations in animals

Agency established a MOU with USDA to clarify roles and responsibilities.

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FDA, NIST to provide key tool for animal biotechnology developers

Project aims to generate standardized measurements for characterizing IGAs in cattle and swine that are developed using genome editing.

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