December 6, 2024 - FDA Roundup: December 6, 2024

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

• On Thursday, the FDA published the draft guidance, “Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics,” which proposes updates to certain agency policies and procedures regarding accelerated approval. Topics addressed by this guidance include how FDA determines which products are candidates for accelerated approval, standards for granting accelerated approval (including postmarketing requirements), and the statutory procedures for withdrawing a product approved under the accelerated approval program. The draft guidance is largely consistent with the information on accelerated approvals contained in the FDA’s 2014 guidance, Expedited Programs for Serious Conditions, with some clarifications and updates to address changes introduced by the 2023 Consolidated Appropriations Act.  
• On Thursday, the FDA updated the outbreak advisory, Outbreak Investigation of Salmonella: Cucumbers (November 2024) to include additional downstream recalls. See the outbreak advisory for more information.  
• On Thursday, the FDA published the Report on Risks and Benefits to Health of Non-Device Software Functions – December 2024. This report highlights the FDA’s Digital Health Center of Excellence findings on the five software functions excluded from the device definition by the 21st Century Cures Act. These software functions range from software that offers administrative support to a health care facility to software that helps patients maintain a healthy lifestyle but is unrelated to the prevention or treatment of a disease. The report analysis includes information from experts external to the FDA, peer-reviewed literature, adverse event report databases, and public input that the FDA received through a public docket.
• On Wednesday, the FDA published the FDA Voices: “Youth Tobacco Product Use Continues to Decline as FDA Actions Build Momentum,” by Dr. Brian King, Director of FDA’s Center for Tobacco Products. Keeping tobacco products out of the hands of youth is central to the FDA’s mission. The recently released 2024 National Youth Tobacco Survey findings are a monumental win for public health: youth tobacco product use has dropped to its lowest level ever reported since the survey began a quarter century ago. Cigarette smoking among youth has reached a historic low. Moreover, reductions in e-cigarette use have fueled recent progress, with use of these products among youth dropping to the lowest level in a decade.
• On Wednesday, the FDA posted a new video in the FDA In Your Day series. This video focuses on FDA’s recent reorganization and specifically the work of the Office of Inspections and Investigations.
• On Wednesday, the FDA granted accelerated approval to Bizengri (zenocutuzumab-zbco, Merus N.V.) for adults with the following: advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy, or advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring a NRG1 gene fusion with disease progression on or after prior systemic therapy. This represents the first FDA approval of a systemic therapy for patients with NSCLC or pancreatic adenocarcinoma harboring an NRG1 gene fusion. In the pooled safety population, the most common adverse reactions (≥10%) were diarrhea, musculoskeletal pain, fatigue, nausea, infusion-related reactions, dyspnea, rash, constipation, vomiting, abdominal pain, and edema.
• On Wednesday, the FDA approved Imfinzi (durvalumab, AstraZeneca) for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The most common adverse reactions (≥20%) in the clinical trial were pneumonitis or radiation pneumonitis and fatigue.
• On Wednesday, the FDA’s Center for Devices and Radiological Health (CDRH) added empty intravenous (IV) containers (product code KPE) to the Medical Device Shortages List with the shortage expected to last through March of 2025. After receiving alerts from health care providers and group purchasing organizations about potential shortages of empty IV bag containers, which are primarily used by compounders, CDRH’s Office of Supply Chain Resilience conducted outreach to assess the constraints. CDRH is working with manufacturers to identify and implement mitigations to address the shortage. Ensuring the public has access to safe and effective medical devices is a top priority for the FDA. We will continue to monitor the situation and assess supply chain mitigations as necessary.
• On Wednesday, the FDA approved for marketing Lungpacer Medical USA, Inc.’s AeroPace System, a first-of-a-kind temporary diaphragm activation system placed with the AeroPace Catheter, indicated to improve ventilator weaning success in patients 18 years or older. Muscles necessary for breathing, such as the diaphragm, may be inactive while a patient is mechanically ventilated. As a result, a type of muscle atrophy, known as Ventilator-Induced Diaphragm Dysfunction, may occur. The AeroPace System stimulates the phrenic nerves, activating the diaphragm to maintain its strength to improve the patient’s ability to wean from a ventilator. The AeroPace System previously received a Breakthrough Device designation and is intended for patients who have been on a mechanical ventilator for at least 96 hours and not yet weaned.

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