FDA guides on Covid-19 con­sid­er­a­tions in cell and gene ther­a­py

Man­u­fac­tur­ers of cell and gene ther­a­pies have a new guid­ance from the FDA that pro­vides pan­dem­ic-re­lat­ed man­u­fac­tur­ing con­sid­er­a­tions.

The guid­ance specif­i­cal­ly ad­dress­es both li­censed and in­ves­ti­ga­tion­al cell and gene ther­a­py (CGT) man­u­fac­ture, and “is in­tend­ed to sup­ple­ment the rec­om­men­da­tions to drug and bi­o­log­i­cal prod­uct man­u­fac­tur­ers pro­vid­ed in FDA’s ‘Good Man­u­fac­tur­ing Prac­tice Con­sid­er­a­tions for Re­spond­ing to COVID-19 In­fec­tion in Em­ploy­ees in Drug and Bi­o­log­i­cal Prod­ucts Man­u­fac­tur­ing; Guid­ance for In­dus­try’ is­sued in June 2020,” ac­cord­ing to the guid­ance.

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