FDA’s biologics chief Peter Marks previews accelerated approval guidance

The FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search is plan­ning to re­lease some cru­cial guid­ance soon for CRISPR and gene ther­a­py de­vel­op­ers on plat­form tech­nolo­gies, ac­cel­er­at­ed ap­provals for rare dis­eases, and po­ten­tial­ly in the “not-too-dis­tant fu­ture,” a plat­form tech­nol­o­gy guid­ance specif­i­cal­ly for genome edit­ing, CBER Di­rec­tor Pe­ter Marks said Tues­day in an Al­liance for a Stronger FDA we­bi­nar.

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