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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER