The FDA has made public filing checklists used internally by Center for Drug Evaluation and Research (CDER) staff to determine if a “submitted application is complete and reviewable.”
The agency hopes that this move will “increase transparency into FDA filing procedures and reduce the prevalence of filing deficiencies, which consumes resources and delay promising treatments.” FDA commissioner Marty Makary touts the step as a move to “make the FDA process easier to understand.”
An initial filing period takes place when a new drug or biologics license application is submitted to CDER during which “staff from each review discipline uses specific checklists to assess whether the application is complete and reviewable.” FDA will refuse to file (RTF) “applications with more significant deficiencies, generally forcing the sponsors to resubmit a complete application. Moving forward, sponsors will be able to see a checklist for each review discipline which performs a filing review.”
RTFs are “time-consuming for FDA and sponsors and can delay innovative treatments from reaching patients. Over the last ten years, more than 200 applications to CDER have resulted in an RTF notification. Applications involving a new molecular entity that receive an RTF experience an average delay of 426 days before application re-submittal.”
