Reg­u­lat­ing new re­gen­er­a­tive ther­a­pies: FDA kicks off the process of rec­og­niz­ing vol­un­tary stan­dards

Thanks to the 21st Cen­tu­ry Cures Act, the FDA has to iden­ti­fy cer­tain vol­un­tary stan­dards to help speed the de­vel­op­ment of re­gen­er­a­tive ther­a­pies, which are gen­er­al­ly de­fined by the agency as cell-, gene- and tis­sue-based ther­a­pies to treat, mod­i­fy, re­verse, or cure a dis­ease.

Mod­eled af­ter a sim­i­lar pro­gram used for med­ical de­vices, CBER this week pub­lished new draft guid­ance ex­plain­ing how its mis­sion to iden­ti­fy and rec­og­nize Vol­un­tary Con­sen­sus Stan­dards (VCS) will help make the de­vel­op­ment and as­sess­ment of so-called re­gen­er­a­tive med­i­cine ther­a­pies, or RMTs, more ef­fi­cient and pre­dictable.

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.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER