FDA offers more clarity on safety testing for cell therapies

The FDA is pro­vid­ing spon­sors of cell ther­a­pies with a new draft guid­ance doc­u­ment on the kinds of safe­ty test­ing they should per­form.

The 14-page guid­ance, pub­lished late last month, pro­vides spon­sors with clar­i­ty on how to car­ry out cell safe­ty test­ing when sub­mit­ting an in­ves­ti­ga­tion­al new drug ap­pli­ca­tion or a bi­o­log­ics ap­pli­ca­tion. The guid­ance lays out how al­lo­gene­ic cell ther­a­pies do car­ry some risk, in­clud­ing con­t­a­m­i­na­tion, or genome changes that can po­ten­tial­ly lead to cells de­vel­op­ing in­to tu­mors.

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