FDA Roundup: July 16, 2024

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

• Today, the FDA announced the revised final guidance Application User Fees for Combination Products. Combination products may be reviewed in a single application or in separate applications for the constituent parts, as appropriate. This guidance explains that combination products for which a single application is submitted should be assessed the applicable user fee associated with that particular type of application. When separate applications are submitted for the constituent parts of a combination product, the document explains how the Agency applies user fees. It also includes revisions for consistency with current medical device and drug user fee programs and legislation. This guidance replaces the final guidance of the same title issued in 2005.
• On Monday, the FDA authorized marketing of DiaSorin Molecular LLC’s Simplexa C. auris Direct, a molecular-based assay intended to detect Candida auris (C. auris) DNA from a skin swab of the armpit or groin from patients suspected of C. auris colonization. The test is intended to help prevent and control C. auris infections in health care settings. The assay may allow health care professionals to evaluate patients for colonization with C. auris faster than traditional culture-based techniques when such testing is needed. Faster detection can help stop the spread of this organism, which is frequently resistant to multiple antifungal drugs and can cause serious infections in hospitalized patients. Test results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory information available to the clinician evaluating the patient. The test is not intended to diagnose or monitor treatment for C. auris infection. This is the latest example of the FDA’s ongoing commitment to helping ensure the development and expansion of tests for emerging infectious pathogens.
• On Monday, the FDA announced organizational changes within the Center for Devices and Radiological Health (CDRH) to help strengthen and better position the Center to meet FDA’s mission to protect and promote the public health. CDRH elevated the Office of Communication and Education into a Super Office that will be responsible for delivering clear, meaningful, insights-based communications, education, and disclosures about medical devices and radiation-emitting products. In addition, CDRH is making structural changes within the Office of Product Evaluation and Quality in both the Office of Clinical Evidence and Analysis and the Office of Health Technology 4: Surgical and Infection Control Devices to help improve efficiencies within the offices and better meet the needs of FDA’s customers. This new reorganization across offices will increase organizational agility and advance the FDA’s efforts to meet commitments under the Medical Device User Fee Amendments (MDUFA) V reauthorization, as well as the 2022-2025 Strategic Priorities.
• On Monday, the FDA issued a guidance, Drugs for the Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and Older. This guidance provides recommendations to sponsors on the clinical development of drugs to treat partial onset seizures (POS) in pediatric patients. It addresses FDA’s current thinking regarding clinical development programs that can support using data approved for the treatment of POS in adults to support treatment options for pediatric patients 1 month of age and older. Previous clinical studies of drugs for the treatment of POS in pediatric patients as young as 1 month have showed a reduction in seizure frequency similar to the response to treatment seen in adults. These historical studies showing similar performance of drugs to treat POS in children and adults further support the use of adult data to show effectiveness from adults to pediatric patients. The revised guidance replaces a guidance, Drugs for the Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older.

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