FDA finalizes rule on using master files in biologics applications

The FDA on Fri­day is­sued a fi­nal rule ex­plain­ing how spon­sors can use mas­ter files — sub­mis­sions to the agency with de­tails on their man­u­fac­tur­ing process­es — in bi­o­log­ics ap­pli­ca­tions, with some new tweaks to the draft ver­sion from 2019.

The fi­nal rule makes of­fi­cial what the FDA’s ex­ist­ing ap­proach has been, which is to use mas­ter files con­tain­ing prod­uct-spe­cif­ic in­for­ma­tion in the ap­pli­ca­tions known as BLAs. Un­der the fi­nal­ized rule, pre­vi­ous­ly-ap­proved bi­o­log­ics may con­tin­ue to in­cor­po­rate ref­er­ences to the drug sub­stance, drug sub­stance in­ter­me­di­ate or drug prod­uct en­closed in a mas­ter file, the FDA said.

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