US FDA’s Confidence In Gene Editing Safety Growing Enough That Regulatory Bar May Be Lowered
By Derrick Gingery,
Pink Sheet
| 11. 01. 2023
Some worries about heritable genetic modifications are subsiding and Center for Biologics Evaluation and Research Director Peter Marks said sponsors should consider the US for regulatory advice and clinical trials in the space.
The US Food and Drug Administration’s growing comfort with gene editing has sparked a more relaxed regulatory approach to the products.
Gene editing is a concerning subject for the FDA because the products could unknowingly cause heritable genetic modifications that harm patients. At first, the agency set high safety standards for gene editing trials to proceed in the US.
Center for Biologics Evaluation and Research Director Peter Marks admitted that the bar may have been set too high initially for some gene editing products. But he said that sponsors now should feel more comfortable discussing development plans with the FDA.
“We may adjust the bar a little bit,” Marks told the Pink Sheet on 16 October. “We would like to recalibrate and for people to know that we’re open to consideration and you don’t have to go to another regulator.”
The change in thinking occurred over the...
Related Articles
By Fyodor Urnov, Time | 08.12.2024
After a lifetime in the field of epigenetics, and nearly 20 years after my colleagues and I coined the term “genome editing,” I will be the first to admit that describing the “epigenome”—a marvelous biological process that guides...
By Joy Zhang, Progress Educational Trust | 08.12.2024
What do China's new ethical guidlines tell us about the country's changing attitude to human genome editing? Professor Joy Zhang reads between the lines...
Recently, China's National Science and Technology Ethics Committee introduced a new set of ethics guidelines on...
By Priyanka Runwal, Chemical and Engineering News | 08.05.2024
Saritee Sanodiya, 26, has spent countless days wondering if she’ll ever live a “normal” life. Growing up, Sanodiya often missed school, frequenting the hospital for sudden, life-threatening drops in her hemoglobin levels and excruciating pain in her joints. High fever...
It’s been a busy couple of months in biopolitics, with developments in the US, UK, China, Japan, and implicitly on Mars. Time for a brief roundup.
• • •
Bioethics needs an update
The National Research Act is now 50 years old. It was signed into law on July 12, 1974, as a direct response to publicity about the 1932 “Tuskegee Study of Untreated Syphilis in the Negro Male.” The Hastings Bioethics Forum celebrated its anniversary with an...