FDA Releases New “Refuse to File” Guidance

The FDA has announced a draft guidance, titled “Refuse to File: NDA and BLA Submissions to CDER.”  The guidance is intended to clarify the circumstances where the CDER (Center for Drug Evaluation and Research) may refuse to file a submitted NDA or BLA, and it reinforces the importance of submitting a complete application.  The FDA notes that over the years, determining whether an application is complete has become increasingly more complex; this guidance aims to alleviate this issue and to restore efficiency to the approval process.

The guidance focuses on the FDA’s policy for refusing to file an NDA or a BLA because it is incomplete or is missing required information.  Complex, significant deficiencies in an application may result in a refusal to file.  These include inadequately organized applications or materially lacking applications; applications containing inadequate information for one or more indications, when multiple indications are submitted in the same application; applications relying on a single trial to demonstrate effectiveness, if the FDA has determined that more than one trial is necessary; applications lacking studies related to the potential abuse of a drug; and a failure to submit data electronically when the FDA has mandated electronic submission.

Comments and suggestions on the draft guidance can be submitted here.