FDA wants to know: What's hold­ing up the de­vel­op­ment of in­di­vid­u­al­ized cell and gene ther­a­pies?

The FDA on Wednes­day said it’s look­ing to bet­ter un­der­stand the sci­en­tif­ic chal­lenges that are slow­ing the de­vel­op­ment of in­di­vid­u­al­ized cell and gene ther­a­pies.

The fo­cus of its re­quest for in­for­ma­tion, which comes on the heels of some heat­ed de­bates be­tween the agency and small spon­sors, cen­ters on the dif­fi­cul­ties around these in­di­vid­u­al­ized cell and gene ther­a­py qual­i­ty and man­u­fac­tur­ing specifics, non­clin­i­cal de­vel­op­ment (e.g., tox­i­col­o­gy, proof of con­cept, biodis­tri­b­u­tion), as­sess­ments of safe­ty and ef­fi­ca­cy, and ad­di­tion­al sci­en­tif­ic needs, best prac­tices, and op­por­tu­ni­ties for col­lab­o­ra­tions.

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