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 New draft guidance explains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 On Tuesday, the agency released draft guidance on what incompleteness means and when it can lead to a “refusal to file” decision.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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