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Through Their Paces

The US Food and Drug Administration is considering tighter rules regarding gene-edited animals, Technology Review reports.

As GenomeWeb reported last week, the agency says it wants to take "a product-specific, science-, and risk-based approach to regulation."

A proposed guidance from the agency says that it is intending to treat edits to an animal's genome as separate new animal drugs and that each tweak then has to go through new animal drug approval requirements. That, Tech Review says, means that FDA would have to evaluate each new gene-edited animal for safety, similar to how it currently handles drugs.

Some researchers say this will create a burden for academic researchers and would limit such work to companies with greater resources, Tech Review notes. "Because of measures like this, almost everything in genetic engineering will have to be done by huge multinational companies," the University of California, Davis' Alison van Eenennaam tells Nature News.

However, Tech Review notes that the public is often wary of genetically modified crops and thus it would make sense for the agency to give modified animals greater scrutiny to avoid a public backlash.

It also points out that these are proposed guidelines and the new Trump Administration may have its own tweaks to make to them.

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