The FDA un­veils a new reg­u­la­to­ry frame­work to speed along gene ther­a­pies, re­ward­ing the lead­ing play­ers

Bioreg­num Opin­ion Col­umn by John Car­roll

The em­pha­sis at the FDA over the past 5 years or so has been on as­sist­ing drug de­vel­op­ers as much as they can to speed up reg­u­la­to­ry re­views and push more drugs in­to the mar­ket. And they are now craft­ing a fi­nal set of reg­u­la­tions aimed at flag­ging through a whole new gen­er­a­tion of gene ther­a­pies in clin­i­cal test­ing at a rapid clip.

In a set of 6 prospec­tive guid­ances post­ed on the FDA web site Tues­day morn­ing, FDA com­mis­sion­er Stephen Hahn com­mit­ted the agency to stay­ing flex­i­ble in hand­ing out des­ig­na­tions that are crit­i­cal to gain­ing ear­ly ap­provals for drugs that claim to be once-and-done but don’t have any­thing close to the da­ta need­ed to prove it.

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