July 21, 2023 - FDA Roundup: July 21, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA Center for Tobacco Products (CTP) announced that the center will host a virtual listening session on Aug. 22, 2023. During this listening session, CTP is requesting feedback on the development of a new 5-year strategic plan for the center, including proposed strategic goals. Registration is now open to request the opportunity to provide open public comment during the session, or to attend in “listen-only” mode. The proposed strategic goals for the 5-year plan, as well as detailed registration information, can be found on the event webpage. In addition to this listening session, the public can submit electronic or written comments to the Federal Register notice. Electronic comments must be submitted, and written comments postmarked, by Aug. 29, 2023.
• On Monday, the FDA published a CDER Conversation where William (Bill) Chong, M.D., director of the Office of Safety and Clinical Evaluation (OSCE) in the FDA’s Office of Generic Drugs (OGD), speaks about the office’s work to review and coordinate information to help ensure the safety of generic drugs on the U.S. market. In 2021, OGD created OSCE to enhance OGD’s work in evaluating generic drug safety before approval and throughout the time it is available for sale in the United States. 
• On Thursday, the FDA approved Cyfendus, a vaccine for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis (anthrax) in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs.  Information on Cyfendus may be found on FDA’s website.
• On Thursday, the FDA approved quizartinib (Vanflyta, Daiichi Sankyo, Inc.), in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive, as detected by an FDA-approved test. FDA also approved LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for Vanflyta.   A boxed warning for quizartinib notes QT prolongation, torsades de pointes, and cardiac arrest. Quizartinib is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), called the Vanflyta REMS.  View full prescribing information for Vanflyta for the full list of adverse reactions.
• On Tuesday, the FDA approved an expansion of indications for the Biosense Webster, Inc., ThermoCool SmartTouch Catheter to add the treatment of symptomatic persistent atrial fibrillation in drug-refractory patients. The clinical evidence used to support the expansion of indications was based solely on an analysis of a dataset comprised of electronic health records from two hospital systems. The FDA worked closely with the study sponsor to ensure that the real-world evidence (RWE) resulting from the analysis was both relevant and reliable. This study was a direct extension of work conducted in one of the National Evaluation System for health Technology (NEST) Test Cases, all of which evaluated the strengths, limitations, and appropriate use of RWE for informing regulatory decisions for multiple device types. This study demonstrates that the NEST system can be used to support premarket regulatory decisions for medical devices. Biosense Webster, Inc. is part of the Johnson & Johnson Family of Companies.
• The FDA’s Complex Innovative Trial Design (CID) Paired Meeting Program is accepting meeting requests for this quarter until September 30, 2023. The CID Paired Meeting Program is designed to facilitate and advance the use of complex adaptive, Bayesian, and other novel clinical trial designs. Led by FDA statisticians with participation from relevant offices across the agency, the CID Paired Meeting Program provides an opportunity for sponsors to interact with experts from FDA at two meetings designed specifically to discuss their proposed CID. Meeting requests may be submitted on a rolling basis and must be received by the last calendar day of each quarter. For more information about the program and to submit a meeting request, please see the Complex Innovative Trial Design Paired Meeting Program.

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