Q&A: FDA’s Peter Marks ready to encourage more accelerated approvals for rare diseases

FDA bi­o­log­ics cen­ter di­rec­tor Pe­ter Marks said the agency plans to en­cour­age spon­sors to use the ac­cel­er­at­ed ap­proval path­way, par­tic­u­lar­ly for rare dis­ease treat­ments, as the agency al­so moves ahead with an Op­er­a­tion Warp Speed-like pi­lot for rare dis­eases lat­er this year.

In an ex­pan­sive in­ter­view with End­points News, Marks said he ex­pects to see more ac­cel­er­at­ed ap­proval ap­pli­ca­tions in the rare dis­ease gene ther­a­py space as well as po­ten­tial­ly in cell ther­a­pies. Marks said the rare dis­ease Op­er­a­tion Warp Speed ef­fort, which he an­nounced in Feb­ru­ary, will “start small” to make sure the agency can work close­ly with the first round of par­tic­i­pants.

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