November 17, 2023 - FDA Roundup: November 17, 2023

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

• Today, to mark the 15th anniversary of the FDA foreign offices, the FDA published an interview with Susan Winckler, who was FDA chief of staff when the first office was opened in Beijing on November 19, 2008. Winckler is now CEO of the Reagan-Udall Foundation, which facilitated the Operational Evaluation of FDA’s Human Foods Program and the subsequent evaluation and report submitted to FDA Commissioner Robert Califf on December 6, 2022. In the interview, Winckler discusses what prompted the establishment of the foreign offices, and how this experience influenced her work on Reagan-Udall’s evaluation of the FDA’s human foods program.
• On Thursday, the FDA announced two new initiatives to help ensure pulse oximetry is equitable and accurate for all patients. To that end, the FDA published a new discussion paper for public comment outlining one possible approach to improve the quality of premarket studies and associated methods used to evaluate the performance of pulse oximeters, taking into consideration patient skin pigmentation and patient-reported race and ethnicity. The agency also announced an upcoming advisory committee on Feb. 2, 2024, where pulse oximeters will be discussed.    
• On Thursday, the FDA approved enzalutamide (Xtandi, Astellas Pharma US, Inc.) for non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). View full prescribing information for Xtandi.
• On Thursday, the FDA approved capivasertib (Truqap, AstraZeneca Pharmaceuticals) with fulvestrant for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. FDA also approved the FoundationOne® CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with capivasertib with fulvestrant. View full prescribing information for Truqap.
• On Thursday, the FDA posted an update on the investigation of elevated lead levels in cinnamon applesauce pouches. The FDA, along with CDC and state and local partners, continues investigating reports of elevated blood lead levels in individuals with reported exposure to Apple Cinnamon Fruit Puree pouches manufactured in Ecuador and sold under WanaBana, Weis, and Schnucks brands. As of November 16, 2023, there have been 34 reports of illness potentially linked to recalled product submitted to the FDA. The FDA is continuing to evaluate incoming adverse reports of illnesses. The FDA’s leading hypothesis is that cinnamon used in these recalled pouches is the likely source of contamination for these products; however, the FDA has not yet been able to collect and test samples of the cinnamon used in the recalled products. The FDA is continuing to work with Ecuadorian authorities to investigate the source of the cinnamon. At this time, FDA has no indication that this issue extends beyond these recalled products, but to further protect public health, the FDA is screening incoming shipments of cinnamon from multiple countries for lead contamination. Additional information is available in the FDA Advisory.
• On Thursday, the Centers for Disease Control and Prevention announced the release of more than 77,000 additional doses of Beyfortus (nirsevimab-alip), a long-acting monoclonal antibody designed to protect infants against severe respiratory syncytial virus (RSV) disease. These additional doses will be distributed immediately to physicians and hospitals through the Vaccines for Children Program and commercial channels – improving the availability for parents seeking to protect their eligible children, particularly those at highest risk of severe illness. CDC and FDA will continue to be in close contact with manufacturers to help ensure the availability of additional doses through end of this year and for early 2024 to meet the demand.
• On Thursday, the FDA approved pembrolizumab (Keytruda, Merck) with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. View the full prescribing information for Keytruda.
• On Thursday, the FDA approved repotrectinib (Augtyro, Bristol-Myers Squibb Company) for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). This is the first FDA approval that includes patients with ROS1-positive NSCLC who have previously received a ROS1 tyrosine kinase inhibitor (TKI), in addition to patients who are TKI naïve. View full prescribing information for Augtyro.
• On Thursday, the FDA issued warning letters to seven online retailers for selling and/or distributing unauthorized e-cigarettes. The unauthorized e-cigarettes are packaged to look like youth-appealing toys and drink containers, including milk cartons, soft drink bottles, and slushies. The products’ design may also help youth conceal the e-cigarettes from adults or be confused with an everyday object and the contents accidently ingested by young children.
• On Thursday, the FDA issued the final guidance: Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act (“506J Guidance”). The FDA is issuing this guidance to address section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as it relates to notifying the FDA of a permanent discontinuance or interruption in the manufacturing of certain devices likely to lead to a meaningful disruption in the domestic supply of that device during, or in advance of, a public health emergency (PHE).
• On Thursday, the FDA issued the draft guidance: Select Updates for the 506J Guidance: 506J Device List and Additional Notifications. This draft guidance provides information to facilitate voluntary notifications on supply chain issues at any time, unrelated to the declaration or potential declaration of a PHE. The Select Update also includes a list of devices, by FDA product code, for which a manufacturer of such devices is required to notify the FDA in accordance with section 506J (“506J Device List”). The FDA intends to incorporate the updates proposed in this draft guidance into the 506J Guidance as one final guidance document after obtaining and considering public comment on these proposed select updates.

For more information, visit the 506J Device List webpage. 

• On Thursday, the FDA issued this final guidance: Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions. Medical device manufacturers are using computational modeling and simulation (CM&S), also called in silico methods, increasingly to help streamline device development and premarket evaluation. This final guidance: 
  • Provides a framework that manufacturers can use to show that computational models used to support regulatory submissions are credible. 
  • Intended to help improve the consistency and transparency of FDA reviews of regulatory submissions that include CM&S methods.
  • Applies to CM&S models that are physics-based or mechanistic. It does not apply to standalone machine learning or artificial intelligence-based models.
  • Provides a framework for demonstrating CM&S credibility through key concepts from the the FDA-recognized standard American Society of Mechanical Engineers (ASME) V&V 40-2018 Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices.

On January 11, 2024, the FDA will host a webinar for industry and others interested in learning more about the guidance.

• On Wednesday, the FDA approved Defencath, a catheter lock solution (CLS) indicated to reduce the incidence of catheter-related bloodstream infections in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC). Defencath is indicated for use in a limited and specific population of patients. Defencath is intended for use as a catheter lock solution only and is not meant to be injected into the body or used as a catheter lock flush product. Each Defencath single-dose vial is designed for use with a single patient as a single instillation in the CVC. Defencath is the third drug to receive approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) and is manufactured by CorMedix, Inc.  
• On Wednesday, the FDA announced a new MITRE report, Next Steps Toward Managing Legacy Medical Device Cybersecurity Risks. The FDA acknowledges that legacy medical devices—those that cannot be reasonably protected against current cybersecurity threats—can pose significant risks to the health care sector. Legacy devices were legally put on the market and may still be broadly in use. To address this important security issue, the FDA contracted with MITRE to develop the report that outlines practical approaches and recommendations that can further drive sector-wide legacy device cyber risk management efforts.
• On Tuesday, the FDA updated the webpage Advancing Alternatives Methods at FDA with new information and a revised format to provide better access to more in-depth content on the FDA’s continuing work to advance new alternative methods for regulatory use. The FDA has a long-standing commitment to the development and use of new technologies that have the potential to provide more timely and more predictive information to assess certain aspects of the FDA-regulated products while also replacing, reducing, and/or refining animal testing. The new webpage will continue to provide updates on this and more of our work to advance alternative methods.

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