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CDRH Adds Empty IV Containers to the Medical Device Shortage List
December 4, 2024
The FDA’s Center for Devices and Radiological Health (CDRH) added empty intravenous (IV) containers (product code KPE) to the Medical Device Shortages List with the shortage expected to last through March of 2025. CDRH is working with manufacturers to identify and implement mitigations to address the shortage.
FDA's Latest Updates on the Hurricane Helene Baxter Recovery
December 12, 2024
We post the latest updates on our webpage: Hurricane Helene: Baxter's manufacturing recovery in North Carolina.
FDA Holds Information Briefing: IV Fluid Shortages
November 21, 2024
The FDA held an informational briefing on the status of the IV fluid shortages, and provided recommendations for health care professionals to check for leaks when using IV fluid products from certain lots where leak defects have been identified.
FDA Issues Draft Guidance on the Accelerated Approval of Drugs and Biologics
December 5, 2024
The FDA issued the draft guidance, “Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics,” which provides updated information on the agency’s proposed policies and procedures regarding accelerated approval.
This draft guidance addresses the criteria for determining which products are candidates for accelerated approval, the standards for granting accelerated approval (including postmarketing requirements), and the procedures for withdrawing a product approved under the accelerated approval program.
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FDA Issues Final Guidance on Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
December 3, 2024
The FDA issued final guidance on "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions."
This guidance is intended to provide a forward-thinking approach to promote the development of safe and effective AI-enabled devices. Additionally, this guidance provides the FDA’s current thinking on predetermined change control plans (PCCPs) and recommendations on the information to include in a PCCP in a marketing submission for an AI-enabled device software function (AI-DSF).
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Emergency Use Authorization (EUA) Updates
FDA Reminds OTC Hand Sanitizer Manufacturers of OMUFA Facility Fees for FY 2025
The FDA is reminding companies who registered with the agency solely to manufacture hand sanitizer during the COVID-19 public health emergency that they are subject to fiscal year (FY) 2025 OMUFA facility fees, unless they delist and deregister before 12 a.m. EST on Dec. 31, 2024, if they no longer manufacture hand sanitizer.
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FDA Revokes EUAs for Four Monoclonal Antibody Products
December 13, 2024
At the request of the individual product sponsors, the FDA has revoked the Emergency Use Authorizations (EUAs) for four respective monoclonal antibody (mAb) products that had been authorized for emergency use as part of the United States government’s response to the COVID-19 public health emergency.
As of December 13, 2024, the EUAs for bebtelovimab, Evusheld (tixagevimab co-packaged with cilgavimab), sotrovimab, and REGEN-COV (casirivimab and imdevimab) have been revoked.
The four mAb products have not been authorized for administration to patients for more than a year due to the high frequency of circulating SARS-CoV-2 variants that are not susceptible to each particular mAb product. Previously, the FDA, at the appropriate time, based on a limitation in each EUA, announced that the respective mAb product was no longer authorized for emergency use. The limitation allowed each EUA to remain in place, and in turn, permitted health care facilities and providers to retain inventory of the particular mAb product in case the susceptibility of future SARS-CoV-2 variants changed. However, the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to these particular mAb products has persisted. In addition, the shelf life for nearly all lots of these products has expired.
The sponsor for each of these revoked EUAs will provide health care facilities and providers with instructions for return and disposal of each respective product.
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Information for Industry and Health Care Providers
Are you a health care professional and want to learn more about the impact of congenital syphilis and syphilis on your patients? Hear directly from the CDC, FDA, HHS, and NIH about what we can do to address the recent surge in syphilis and its impact on individuals, pregnant people and babies.
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Recently, the FDA completed one of its largest transformations, impacting almost every part of the agency. This installment of FDA In Your Day highlights two of the many examples of the important work the FDA is doing every day to keep us safe!
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CDER establishes new Center for Real-World Evidence Innovation
December 12, 2024
The FDA’s Center for Drug Evaluation and Research (CDER) announced the new CDER Center for Real-World Evidence Innovation (CCRI) which aims to coordinate, advance, and promote the use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making across CDER.
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