nda and bla submissions

FDA may “Refuse to File” your NDA/BLA submission

New draft guideline clarifies the circumstances where an application can be "Refuse to File"

New draft guideline clarifies the circumstances where an application can be "Refuse to File"
January 4, 2018
Incompleteness of an NDA or BLA submission may result in refuse to file, meaning that FDA will not review the application and therefore the approval process would be delayed.
Determining whether an application is complete has become increasingly more complex. The guidance “Refuse to File: NDA and BLA Submissions to CDER” focuses on the FDA’s policy for refusing to file an NDA or a BLA submitted to the Center for Drug Evaluation and Research (CDER). These deficiencies include:
  •  Materially lacking or inadequately organised applications;
  • Applications containing inadequate information for one or more indications;
  • Applications relying on a single trial to demonstrate effectiveness, if FDA has previously determined that more than one trial is needed;
  • Applications missing studies related to the potential abuse of a drug;
  • A failure to submit data electronically.
We will cover this and many other FDA-related topics at our annual flagship FDA Open Seminars next year in Munich and Barcelona. Don’t miss out!
If you have any questions regarding the completeness of your FDA electronic submissions or if you need a complete support for your US submission in the correct format, please contact us by email at fda@asphalion.com

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