October 31, 2023 - FDA Roundup: October 31, 2023

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

• On Monday, the FDA provided an update from our ongoing postmarket evaluation of Essure by posting interim results from the postmarket surveillance study, after all patients have completed three years of follow up. Five-year follow-up of patients in the study is ongoing. Final analyses of endpoints will be performed when the study concludes, after all patients have completed five years of follow-up and final adjudication of the data is completed. The FDA remains committed to collecting and providing updates on the long-term safety and effectiveness information about Essure, a permanently implanted birth control device for women. Although Essure has not been available for implantation in the United States since December 2019, the FDA continues to monitor the product’s safety through an FDA-required postmarket surveillance (“522”) study and other activities.
• On Friday, the FDA accepted the first master file for the Radiation Sterilization Master File Pilot Program, a voluntary pilot program intended to help contract sterilizers and medical device manufacturers make changes — or advance alternative ways — to the way they sterilize FDA-approved medical devices. The master file delineates the qualification protocols, cycle parameters, and product definition that are utilized to make site changes for an existing cycle, change radiation sources, lower the radiation dose, or change from an Ethylene Oxide (EO) cycle to radiation for an approved PMA product, in a least burdensome regulatory approach. The acceptance of this master file into the Radiation Sterilization Master File Program represents another major stride in FDA’s efforts to foster new or improved modalities that are safe and effective for sterilizing medical devices while reducing the overall reliance on EO, helping reduce emissions that could be harmful for the environment. The master file was submitted by Steris Corporation, Sterilization for Medical Devices | FDA.
• On Friday, the FDA approved toripalimab-tpzi (LOQTORZ, Coherus BioSciences, Inc.) with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC). The FDA also approved toripalimab-tpzi as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. View full prescribing information for LOQTORZI.
  “Today’s approval of Loqtorzi is the first approval in the United States of a drug to treat nasopharyngeal carcinoma. When combined with chemotherapy this drug has demonstrated an improvement in overall survival as well as delaying the progression of disease in patients with metastatic or recurrent, locally advanced disease who had not received prior chemotherapy,” stated Richard Pazdur.
• On Thursday, the FDA announced that the outbreak of Listeria monocytogenes infections linked to recalled dairy and non-dairy products with the Ice Cream House logo sold at Ice Cream House and Real Kosher Ice Cream has ended, and the investigation is complete. The Ice Cream House has voluntarily recalled all dairy and non-dairy products with the Ice Cream House logo. Recalled products include dairy and non-dairy (parve). Real Kosher Ice Cream has also voluntarily recalled all flavors of Soft Serve On The Go 8-oz ice cream cups. Since the recall, the company started placing a label that includes a lot code on their products. If consumers have products in their freezers without a lot code, they should be thrown out. More information on this outbreak can be found here.
   

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