New US FDA Draft Guidance

Refuse to File: NDA and BLA Submissions to CDER

The purpose of this guidance is to clarify circumstances under which the FDA’s Center for Drug Evaluation and Research (CDER) may refuse to file a new drug application (NDA) or supplemental NDA (21 CFR 314.101(d)) or a biologics license application (BLA) or supplemental BLA (21 CFR 601.2) for a therapeutic biological product regulated by CDER,2 and to underscore the importance of submitting a complete application to minimize the chance of a refuse-to-file (RTF) action by the FDA. In particular, this guidance focuses on the FDA’s policy for refusing to file an NDA under § 314.101(d)(3) when the NDA is incomplete because it does not on its face contain information required under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 314.50.

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

Read the pdf
Copyright Widler & Schiemann AG 2015. All Rights Reserved. /