FDA Roundup: January 9, 2024

FDA News Release

• For Immediate Release: January 09, 2024

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

• On Jan. 10, please join OCE at 2:00 pm for Conversations on Cancer: Bringing Innovation to People Facing Cancer. This discussion will highlight oncology drug approvals in 2023. We will review a wide range of cancers, approval of novel drugs, and new uses for previously approved drugs. The discussion will focus on the most transformative oncology drug approvals for 2023 and showcase OCE’s commitment to protecting and advancing patient care through approval of life-altering treatments for cancer patients. Registration Link: https://www.surveymonkey.com/r/FTYFN3H. The livestream YouTube link provided upon registration.
• Today, the FDA issued a Letter to Health Care Providers to alert providers and facilities about the potential for exposure to certain chemicals that may be released when General Electric (GE) HealthCare accessory components called the EVair or Evair03 compressor are used with certain ventilators, and to help ensure providers are aware of the manufacturer’s recall notice and recommended actions.
• On Monday, the FDA updated the final guidance: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. The FDA now considers vaporized hydrogen peroxide (VHP) as an Established Category A sterilization process. The updated guidance provides industry with revised recommendations on the information to provide in future 510(k) submissions that use VHP.
• On Monday, the FDA announced a town hall entitled, Medical Device Sterilization Town Hall: Overview of Sterilization Landscape and Role of Ethylene Oxide. This town hall will be held on Wednesday, January 10, 2024, at 2:00 p.m. ET and will discuss takeaways from the 2019 Advisory Committee meeting focused on ethylene oxide sterilization (EtO), the current medical device sterilization landscape, supply chain integrity, and the need for forward-looking, innovative and collaborative activities.
• On Monday, the FDA’s Coordinated Outbreak Response & Evaluation (CORE) Network released its first annual report summarizing its investigations of outbreaks and adverse events linked to FDA-regulated human foods for the 2022 calendar year. The FDA’s CORE Network was established in 2011 with the mission to find, stop, and prevent foodborne illness outbreaks. This is accomplished through disease surveillance, outbreak response, post-response activities, and collaboration with CDC and state and local public health agencies. Every year, CORE evaluates and responds to numerous foodborne outbreaks related to FDA-regulated food products. CORE investigations also resulted in numerous public health actions, including recalls, public health advisories, Warning Letters, FDA prevention strategies, a country-wide Import Alert, and a Consent Decree. These are further described in the report.  
• On Friday, the FDA published its report on new drug approvals in 2023, Advancing Health Through Innovation: New Drug Therapy Approvals. This report features novel approvals, meaning drugs that have not previously been approved in the U.S, along with notable approvals of drugs for new and expanded uses, new formulations, and new dosage forms. The report also highlights drugs for patients with few or no treatment options, including those with rare diseases. 
• On Friday, the FDA provided updates on the Investigation of Elevated Lead Levels in Cinnamon Apple Puree Pouches. In the FDA’s testing of the recalled products and the cinnamon collected from the Austrofoods facility, the agency has found chromium. Due to limitations in available testing methods, the FDA was not able to definitively determine the form of chromium in the cinnamon apple puree sample (i.e., whether the chromium present is chromium (III) or chromium (VI)). The lead-to-chromium ratio in the cinnamon apple puree sample is consistent with that of lead chromate (PbCrO4) (which contains chromium (VI)), but this is not a definitive indicator that lead chromate or chromium (VI) (the more toxic form of chromium) was present. People who ate recalled products, especially if they had elevated blood lead levels, may have been exposed to chromium and should inform their healthcare provider so they can monitor health and provide supportive care, as needed. Healthcare providers can refer to CDC’s Clinician Outreach and Communication Activity (COCA Now) announcement for information for additional guidance.