When can FDA 'refuse to file' NDAs and BLAs? New draft guid­ance ex­plains

When a new drug ap­pli­ca­tion or bi­o­log­ics li­cense ap­pli­ca­tion is deemed in­com­plete by the FDA, the agency can de­cide not to re­view the ap­pli­ca­tion. So when can this oc­cur? On Tues­day, the agency re­leased draft guid­ance on what in­com­plete­ness means and when it can lead to a “re­fusal to file” de­ci­sion.

Ex­plained sim­ply: Refuse-to-file ac­tions al­low the FDA to in­form a spon­sor as quick­ly as pos­si­ble of de­fi­cien­cies in an NDA or BLA, help­ing com­pa­nies to cor­rect such is­sues rather than wait for FDA to is­sue a com­plete re­sponse let­ter.

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