FDA posed a sprawl­ing set of ques­tions for two-day gene ther­a­py hear­ing. Here's what com­pa­nies and ex­perts will be watch­ing for

Gene ther­a­py is hav­ing a mo­ment. Once con­fined to aca­d­e­m­ic labs and a cou­ple of com­pa­nies, the field now en­com­pass­es hun­dreds of tri­als, dozens of com­pa­nies and bil­lions of in­vest­ment dol­lars.

With greater pow­er, though, comes greater re­spon­si­bil­i­ty. The FDA is ask­ing a pan­el of out­side ex­perts to try and de­fine those re­spon­si­bil­i­ties as they de­bate a lengthy list of 15 ques­tions Thurs­day and Fri­day, in a two-day marathon meet­ing on the fu­ture of a field that has promised one-time treat­ments for some of the most fa­mous and fa­tal dis­eases known to med­i­cine.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.