FDA Roundup: October 20, 2023

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

• Today, the FDA announced the fiscal year (FY) 2024 fee rates and payment procedures for animal drugs subject to user fees under the Animal Drug and Animal Generic Drug User Fee Amendments of 2023. The Animal Drug User Fee Act (ADUFA), originally signed into law in 2003, authorizes the FDA to collect fees for certain animal drug applications and supplemental applications, products, establishments, and sponsors of animal drug applications and/or investigational animal drug submissions. The Animal Generic Drug User Fee Act (AGDUFA), originally signed into law in 2008, authorizes the FDA to collect user fees for certain abbreviated applications for generic new animal drugs, generic investigational new animal drug files, generic new animal drug products, and from certain sponsors of abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. These resources supplement funding provided by Congressional budget authority and serve to enhance the performance of the drug review process ensuring that new animal drugs and generic new animal drugs are safe and effective for animals, and that food derived from treated animals will be safe for consumption. ADUFA V and AGDUFA IV reauthorize the FDA to collect user fees through FY 2028.
• On Thursday, the FDA authorized an extension for the shelf life of Gohibic (vilobelimab) for specific lots, from 24 months to 30 months. Gohibic is currently authorized for emergency use to treat COVID-19 in certain hospitalized adults. The FDA granted this extension following a thorough review of data submitted by InflaRx GmbH. As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry. This extension applies to all retained product that has been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization. Additional information about the use of Gohibic can be found in the FDA statement describing the authorization for this product.
• On Thursday, the FDA removed certain ventilation-related products (product codes: CBK and NOU) from the medical device shortage list. The FDA publishes a device shortage list to provide transparency to the American public, particularly those who use or purchase medical devices. The medical device shortages list reflects the categories of devices the FDA has determined to be in shortage. For information about how the FDA determines it is appropriate to remove or add product codes from the device shortage list, please visit Supply and Shortages of Medical Devices: Frequently Asked Questions.
• On Thursday, the FDA added 171 devices to the list of artificial intelligence and machine learning (AI/ML)-enabled devices legally marketed in the United States by 510(k) clearance, granted De Novo request, or premarket approval. With this update, the FDA also added insights about trends based on analyses of the data. This list is not meant to be an exhaustive or comprehensive resource of AI/ML-enabled medical devices. Rather, it is a list of AI/ML-enabled devices across medical disciplines, based on publicly available information. The FDA maintains this list to increase transparency about AI/ML-enabled devices in this rapidly progressing field.

 Additional Resources: 

• FDA Newsroom 

Media Contact: FDA Office of Media Affairs, 301-796-4540 

Consumer Inquiries: 888-INFO-FDA 

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