Pan­dem­ic trav­el re­stric­tions force FDA to de­lay a BLA re­view — in­volv­ing a site in­spec­tion in Ko­rea

In an un­usu­al move, the FDA is ap­par­ent­ly de­fer­ring ac­tion on a BLA be­cause it was un­able to con­duct a man­u­fac­tur­ing site in­spec­tion on time.

Spec­trum Phar­ma­ceu­ti­cals’ ap­pli­ca­tion for eflape­gras­tim is now in lim­bo as it works with the FDA to ex­pe­dite its trip to the Han­mi plant in South Ko­rea, where the drug sub­stance is man­u­fac­tured. Giv­en pan­dem­ic trav­el re­stric­tions, reg­u­la­tors were un­able to in­spect the site dur­ing the cur­rent re­view cy­cle, ac­cord­ing to a state­ment put out Mon­day morn­ing — two days af­ter the orig­i­nal PDU­FA date.

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