A go-go FDA is open­ing up the fast lane to re­gen­er­a­tive med ap­provals

The FDA on Thurs­day launched a new pol­i­cy frame­work for re­gen­er­a­tive med­i­cine, build­ing off a pre­vi­ous frame­work from 2005, as part of ef­forts to bring new cell, stem cell and tis­sue prod­ucts to pa­tients as ef­fi­cient­ly as pos­si­ble while man­ag­ing the pro­lif­er­a­tion of un­scrupu­lous ac­tors hawk­ing un­proven ther­a­pies.

FDA’s an­nounce­ment in­clud­ed the re­lease of two new draft guid­ance doc­u­ments – one on ways to ex­pe­dite ap­provals for re­gen­er­a­tive med­i­cines for se­ri­ous con­di­tions and one on med­ical de­vices used with re­gen­er­a­tive ther­a­pies – and two fi­nal guid­ance doc­u­ments of­fer­ing clar­i­ty on when cell and tis­sue-based prod­ucts would be ex­cept­ed from the reg­u­la­tions and clar­i­fy­ing how the agency in­ter­prets the reg­u­la­to­ry de­f­i­n­i­tions of “min­i­mal ma­nip­u­la­tion” and “ho­mol­o­gous use.”

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