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FDA Clears Way For Faster Personalized Gene Editing Therapy (financialpost.com)

(Friday October 31, 2025 @06:50PM (msmash) from the up-next dept.)


A top United States regulator plans to [1]unveil a faster approach to approving custom gene-editing treatments , a move designed to unleash a wave of industry investment that will yield cures for patients with rare diseases. From a report:

> Vinay Prasad, who oversees gene therapies at the Food and Drug Administration, said scientific advances, like Crispr, have forced the agency to relax some of its strict rules. As an example, he cited the case of 10-month-old KJ Muldoon, who this year became the first person in history to have his genes custom edited to cure an inherited disease.

>

> "Regulation has to evolve as fast as science evolves," Prasad said in an interview with Bloomberg News. The agency is "going to be extremely flexible and work very fast with the scientists who want to bring these therapies to kids who need it." Prasad plans to publish a paper in early November outlining the FDA's new approach. He predicted it will spark interest in developing treatments for conditions that may affect only a handful of people.



[1] https://financialpost.com/technology/fda-gene-editing-therapy



What? (Score:2)

by shanen ( 462549 )

'Nuff said.

good times (Score:2)

by awwshit ( 6214476 )

Nothing like experimenting on your kids.

Re: (Score:3)

by jedidiah ( 1196 )

Sometimes experimentation is the only thing standing between you and certain death. None of us would be surviving cancer if not for patients being experimented on.

Beyond terminal illnesses, the regulatory burdens should be very high and not lowered because something shiny and new comes along.

A Good or Bad Thing? (Score:2)

by crunchy_one ( 1047426 )

I don't have the background to know whether this is a good idea, or not. It's a comfort to know that with Secretary Leather Face in charge, no one at the FDA knows either.

Re: (Score:1)

by Insanity Defense ( 1232008 )

Once he hears of it all support will be cancelled.

Re: (Score:2)

by Gilgaron ( 575091 )

Tentatively, it's good because these kinds of treatments can't really be bulk produced the same way drugs can. The situation as you describe does make one wonder if any thought for the safety of the patients will be considered, or if letting the chips fall where they may fits better into their half ass eugenics movement.

incentive program, n.:
The system of long and short-term rewards that a corporation uses
to motivate its people. Still, despite all the experimentation with
profit sharing, stock options, and the like, the most effective
incentive program to date seems to be "Do a good job and you get to
keep it."