12 December 2017 - When a new drug application or biologics license application is deemed incomplete by the US 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On Tuesday, the agency released draft guidance on what incompleteness means and when it can lead to a "refusal to file" decision.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 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.

Incomplete applications, including applications for which minor components have not been received within 30 calendar days after receipt of the original application, as may have been agreed upon at a pre-submission meeting, may also be refused for filing, the agency explains.

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