10 January 2018 - According to US FDA regulations, the regulatory agency may refuse to file a new drug application or biologics license application when either is deemed incomplete.

Such refuse-to-file (RTF) actions are regulatory tools to prevent multiple-cycle reviews of deficient applications, which can be time-consuming, costly, and unnecessary.

However, the number of RTF actions has been increasing over the years, with each incident affecting both the FDA and the applicant in different yet considerable ways. To clarify the agency’s basis for determining the completeness of an application, the FDA has drafted new guidance on circumstances that may lead to RTF action.

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