The Food and Drug Administration (FDA) is implementing a new strategy to provide experimental gene therapies to patients with rare disorders without going through clinical trials. This framework could grant these patients access to individualized therapies, but experts are divided over whether the regulatory change is safe enough for patients. Dr. Senthil Bhoopalan , a genome-editing expert at St. Jude's Children Research Hospital in Tennessee, said that, although the framework is still emerging and the details require more discussion between the public and stakeholders, "it's an exciting step in the right direction." Arthur Caplan , a medical ethicist at New York University, said more pressure to permit access to new therapies has led the FDA "to allow more risk to subjects, and more risk of failure post-approval, by being willing to accept weaker evidence." Before receiving FDA approval, most therapies require clinical trials with hundreds or thousands of participants to show a drug is safe and works.…