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FDA Roundup: December 20, 2024

The U.S. Food and Drug Administration (FDA) has issued a summary of the latest developments as of December 20, 2024. This roundup highlights various important updates including guidance on clinical decision support software, new approvals for medical devices, and public health surveillance initiatives.

Clinical Decision Support Software FAQs

The FDA has provided guidance through FAQs intended for developers and sponsors of clinical decision support (CDS) software. These FAQs clarify the software's classification as a medical device according to recent guidance. This initiative aims to assist stakeholders in navigating regulatory expectations and ensuring compliance with medical standards.

Expansion of OraQuick HIV Self-Test

In a landmark ruling, the FDA has approved a premarket approval application supplement for the OraQuick Human Immunodeficiency Virus (HIV) Self-Test. This significant change lowers the age eligibility for users from 17 to 14. The OraQuick test allows adolescents to access HIV testing easily from their homes, potentially improving early detection rates in this age demographic. The test, which checks for antibodies to HIV, includes thorough instructions and support resources to guide users through the process.

FDA's Efforts in the Pacific Islands

A Viewpoint article published by the FDA's Office of Inspections and Investigations discusses the ongoing collaboration between the FDA and local governments in the Pacific Islands to ensure product safety. This partnership is critical to regulate products that enter the U.S. from this significant global sourcing region. Listeners can find more insights by tuning into a new podcast series detailing the FDA’s initiatives and impacts in Guam and its surrounding regions.

Updates on Salmonella Infection Outbreak

The FDA has expanded its investigation into the Salmonella Typhimurium infections linked to cucumbers, as new cases have emerged. The agency continues to monitor the situation and will provide further guidance once investigations conclude.

Approval of Tryngolza for Rare Genetic Disorder

Another notable approval this week, Tryngolza (olezarsen), has received FDA clearance for the treatment of familial chylomicronemia syndrome (FCS), a rare genetic disorder that leads to extremely high triglyceride levels. Tryngolza represents a first-in-class option for patients struggling with this condition, utilizing a novel mechanism of action that differentiates it from other treatment modalities. Patients and caregivers should be aware of potential side effects, which include injection site reactions and decreased platelet counts.

Resolution of Tirzepatide Shortage

The FDA has revisited its previous assessment regarding the shortage of tirzepatide. As of now, the agency has concluded that the shortage has been resolved, allowing patients access to this critical medication once again.

Educational Video on Pertussis

In its commitment to public education, the FDA released a new video in its “FDA In Your Day” series, focusing on whooping cough (pertussis) and preventative measures. This resource aims to inform consumers about vaccination and protective strategies to reduce the spread of this illness.

Approval of Ryoncil for Pediatric Patients

Ryoncil (remestemcel-L-rknd), an innovative allogeneic mesenchymal stromal cell therapy, has gained FDA approval for treating steroid-refractory acute graft versus host disease (SR-aGVHD) in children aged two months and above. This approval marks a significant advancement in therapeutic options available to pediatric patients facing serious health challenges.

Anaplastic Lymphoma Kinase Positive Lung Cancer Treatment

This week, the FDA authorized Ensacove (ensartinib) for adults diagnosed with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer. The approval offers hope and new options for patients who have not yet undergone treatment with an ALK-inhibitor, expanding the available options in oncology.

Ongoing Monitoring of PFAS Levels

In follow-up to previous findings regarding per- and polyfluoroalkyl substances (PFAS), the FDA has announced updates from its seafood survey conducted from October 2022 to September 2024. All analyzed samples from processed clams originating in China contained detectable levels of PFAS.

Advisory on Amanita Muscaria

The FDA has warned food manufacturers that Amanita muscaria, a mushroom known for its hallucinogenic effects, is not authorized for use in food products. The agency emphasizes the importance of food safety and public health and recommends avoiding products containing this mushroom.

Update on E. coli Outbreak

The FDA has issued a final advisory regarding an earlier outbreak of E. coli associated with organic whole and baby carrots from Grimmway Farms. Following inspections and environmental testing, the outbreak has been resolved, and appropriate corrective actions are being discussed with the involved parties.

These updates underscore the FDA's ongoing commitment to ensure public health and safety, as well as the crucial role it plays in guiding medical advancements and regulatory compliance across the nation.