December 15, 2023 - FDA Roundup: December 15, 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 updated the breast implants web pages to share the latest information on:
  • Risks and complications related to breast implants 
  • Reports of squamous cell carcinoma (SCC), various lymphomas other than Breast Implants Associated Anaplastic Large Cell Lymphoma( BIA-ALCL), and mesenchymal tumors, including sarcoma.
  • Labeling for approved breast implants.
  • Medical Device Reports posted between January 1, 2008, and June 30, 2023, for systemic symptoms in women with breast implants.
  • Medical Device Reports from U.S and worldwide cases found in literature for breast implants associated with anaplastic large cell lymphoma (BIA-ALCL) and postmarket safety of breast implants.
• Today, the FDA issued draft guidance intended to help animal drug sponsors pursuing Priority Zoonotic Animal Drug (PZAD) designation for a new animal drug. PZADs are new animal drugs that have the potential to prevent or treat a zoonotic disease in animals, including a vector-borne disease, that has the potential to cause serious adverse health consequences for, or serious or life-threatening diseases in humans. This guidance is intended to expedite the development and review of these drugs. The FDA is accepting public comments on the draft guidance until February 16, 2024. 
• On Thursday, the FDA approved belzutifan (Welireg, Merck & Co., Inc.) for patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI). The most common adverse reactions (≥25% incidence) in patients receiving belzutifan were decreased hemoglobin, fatigue, musculoskeletal pain, increased creatinine, decreased lymphocytes, increased alanine aminotransferase, decreased sodium, increased potassium, and increased aspartate aminotransferase. View full prescribing information for Welireg.
• On Thursday, the FDA announced that the Center for Devices and Radiological Health (CDRH) began participating in three new collaborative communities in the medical device ecosystem. These new collaborations focus on topics related to artificial intelligence, infection management, and diagnostic tests.
• On Thursday, the FDA announced the issuance of nine warning letters to manufacturers and distributors of unapproved antimicrobial drugs for nonfood minor animal species such aquarium fish and pet birds. These products are marketed over the counter without medical oversight, which can contribute to the development of antimicrobial resistance.
• On Thursday, the FDA updated the public health advisory for the investigation of Listeria monocytogenes linked to peaches, plums, and nectarines, to include a link to the updated recall announcement which now includes a list of retail locations that the FDA has reason to believe received the recalled peaches, plums & nectarines This list will be updated as additional information is collected by the FDA. More information is available in the public health advisory.
• On Wednesday, the FDA announced it will open the Voluntary Qualified Importer Program (VQIP) application portal for fiscal year (FY) 2025. VQIP is a voluntary fee-based program that provides importers, who achieve and maintain control over the safety and security of their supply chains, the benefits of expedited review and importation of human and animal foods into the United States.  
• On Wednesday, the FDA approved the PulseSelect Pulse Field Ablation (PFA) system for cardiac electrophysiological mapping (stimulation and recording) and to treat atrial fibrillation (Afib) using electrical pulses to ablate cardiac tissue. According to the Centers for Disease Control and Prevention, it is estimated that 12.1 million people in the United States will have the condition in 2030. The PulseSelect PFA system has several components, including a generator and a loop catheter that ablate tissue with fast electrical pulses that form holes in the thin membrane around each cell (irreversible electroporation) instead of with thermal energy. In 2018, the FDA granted Breakthrough Devices designation to the PulseSelect PFA system because it represented a breakthrough technology that could provide more effective treatment for a life-threatening or irreversibly debilitating condition, among other criteria. Conventional thermal ablation for the treatment of Afib may lead to adverse events such as injury to the esophagus. Today’s approval brings to market an alternative treatment modality that may reduce such risks. The FDA granted approval, subject to certain post-approval study requirements, of the PulseSelect PFA system to Medtronic, Inc.
• On Wednesday, the FDA announced that the investigation of Salmonella linked to Onions is over and CDC announced that the outbreak has ended. CDC reports a total of 80 illnesses in 23 states. There has been a total of 18 hospitalizations and one death associated with this incident. The last illness onset was November 11, 2023. FDA’s investigation is complete. More information is available in the public health advisory.
• On Wednesday, the FDA approved eflornithine (IWILFIN, USWM, LLC) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. The most common adverse reactions (≥5%), including laboratory abnormalities, were otitis media, diarrhea, cough, sinusitis, pneumonia, upper respiratory tract infection, conjunctivitis, vomiting, pyrexia, allergic rhinitis, decreased neutrophils, increased ALT, increased AST, hearing loss, skin infection, and urinary tract infection.  This represents the first FDA approval of a therapy intended to reduce the risk of relapse in pediatric patients with HRNB. View full prescribing information for IWILFIN.
• On Tuesday, the FDA sent a safety alert advising restaurants and retailers not to serve or sell and consumers not to eat chopped clams likely harvested from a prohibited area  in Massachusetts and distributed by Red’s Best.
• On Tuesday, the FDA authorized marketing for Ankon Technologies’ NaviCam ProScan, software as a medical device. The device is based on artificial intelligence (AI) technology, designed for use with the NaviCam Small Bowel Capsule Endoscopy System. Patients with suspected small bowel bleeding swallow a disposable, single use camera pill, which takes pictures (images) of the small bowel as it travels through the digestive tract. A health care professional then reviews the images to identify any bleeding in the small bowel. NaviCam ProScan is indicated to aid in decreasing the time to review capsule endoscopy images. ProScan uses AI to analyze the images and presents the reader with any images that indicate bleeding. NaviCam ProScan is not intended to replace a thorough review of the video, nor is it intended to replace clinical decision making.

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