Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease; Draft Guidance for Industry; Availability
Published Date: 1/7/2025
Notice
Summary
The FDA just released a draft guide for companies making genetically changed food animals, like pigs and rabbits, to study diseases. If these animals are used carefully in labs, companies might not need FDA approval before selling them. Comments on this draft are open until March 10, 2025, so now’s the time to speak up!
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Developers May Not Need Premarket Approval
The FDA released draft Guidance for Industry #251 about heritable intentional genomic alterations (IGAs) in food-producing animals like swine and rabbits when marketed as disease models for research under contained conditions. The draft says that if, after FDA Center for Veterinary Medicine (CVM) review of risk factor data, an IGA product fits Category 2, FDA generally may not expect the developer to submit an application or get CVM approval before marketing the animals.
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