SILVER SPRING, Md., Nov. 17, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
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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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
SOURCE U.S. Food and Drug Administration