The FDA has released new draft guidance for industry on refuse-to-file (RTF) action taken by the FDA. The document seeks to clarify circumstances under which the FDA’s Center for Drug Evaluation and Research (CDER) may refuse to file a new drug application (NDA), supplemental NDA, or a Biologics License Application (BLA), or supplemental BLA for a product regulated by CDER.
The FDA has released new draft guidance for industry on refuse-to-file (RTF) action taken by the FDA. The document seeks to clarify circumstances under which the FDA’s Center for Drug Evaluation and Research (CDER) may refuse to file a new drug application (NDA), supplemental NDA, or a Biologics License Application (BLA), or supplemental BLA for a product regulated by CDER. The guidance highlights the importance of submitting a complete application to minimize the chance of an RTF action.
The FDA typically either files an NDA or BLA within 60 days of receipt or informs the applicant of an RTF action. The filing of an application signals that the agency has made a threshold determination that the application’s content is sufficiently complete to permit a thorough review of its merits.
FDA regulations describe the possibility that the agency will consider an application incomplete if it is obviously deficient in a way that will make a review impossible, but the agency acknowledges in its new draft guidance that the administrative threshold to determine completeness has increased in recent years. The guidance points to pre-submission meetings between applicants and the FDA as opportunities to reach agreements regarding the content of a complete application, as well as agreement on submission of minor components that may be submitted within a 30-day period after the original application is submitted (though a rolling review period is available for fast-track designations). These additional submissions can add to the complexity of determining an application’s completeness. However, timely reviews of applications—provided for under user fee act agreements—make it imperative that the agency exercise its RTF authority when necessary to optimize the applicant’s and the FDA’s time and resources.
The types of application deficiencies that may result in an RTF action by day 60 are as follows:
Within 30 days after an RTF notification, an applicant can request an informal conference with the FDA to discuss whether the agency should file an application despite the RTF action.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Eye on Pharma: Interchangeability Labels and Expanded Biosimilar Partnerships
May 29th 2025The FDA designates 2 biosimilars as interchangeable, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
What Stands in the Way of Biosimilar Use Across MENA Countries?
May 21st 2025Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the Middle East and North Africa (MENA) region is tangled in a web of distrust, inconsistent policies, and deep-rooted cultural preferences for branded drugs.