FDA drafts new guidance on manufacturing cell and gene therapies, postmarket trial noncompliance

The FDA on Thurs­day re­leased two new draft guid­ance doc­u­ments re­lat­ed to the man­u­fac­ture of cell and gene ther­a­pies, one di­rect­ing man­u­fac­tur­ers to car­ry out suf­fi­cient risk as­sess­ments be­fore chang­ing any man­u­fac­tur­ing prac­tices, and an­oth­er on what hap­pens if spon­sors don’t com­ply with FDA-man­dat­ed post­mar­ket­ing stud­ies.

For cell and gene ther­a­pies (CGT), FDA says in the draft guid­ance that while they are reg­u­lat­ed un­der the ex­ist­ing frame­work for bi­o­log­ics, CGT man­u­fac­tur­ing faces sev­er­al unique chal­lenges, like lim­it­ed knowl­edge of prod­uct qual­i­ty at­trib­ut­es and short shelf life, that may dif­fer from oth­er bi­o­log­ics.

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