Amid ap­pli­ca­tion tsuna­mi, FDA's top cell and gene ther­a­py leader to re­tire in March

The FDA is in a bind and what it needs most right now is the ex­per­tise nec­es­sary to vet a mas­sive pipeline of cell and gene ther­a­pies com­ing down the pike.

Less than 30 of these ther­a­pies have so far been ap­proved by the FDA, and Pe­ter Marks, head of the FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search, told End­points News in an emailed state­ment that there are now 2,500 ap­pli­ca­tions pend­ing, and many of the meet­ings with spon­sors are falling be­hind.

Endpoints News

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