FDA of­fi­cials, ex­perts dis­cuss im­pact of Covid-19 on cell and gene ther­a­pies

While the FDA is still re­ceiv­ing in­ves­ti­ga­tion­al new drug ap­pli­ca­tions (INDs) for cell and gene ther­a­pies, of­fi­cials are con­cerned about the im­pact of the Covid-19 pan­dem­ic on clin­i­cal tri­als.

“It’s clear that COVID-19 has ad­verse­ly af­fect­ed all as­pects of de­vel­op­ment of cell and gene ther­a­pies,” said CBER di­rec­tor Pe­ter Marks at the Al­liance for Re­gen­er­a­tive Med­i­cine’s Meet­ing on the Mesa. “For some of the stud­ies that are on­go­ing there are some re­al chal­lenges to over­come in terms of end­points that may have been missed.”

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