FDA Roundup: January 12, 2024

SILVER SPRING, Md., Jan. 12, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

On Wednesday, the FDA issued a safety alert, advising restaurants and retailers not to serve or sell and consumers not to eat certain whole, live scallops believed to be harvested from a prohibited area in Massachusetts and distributed by Intershell International Corp.
On Wednesday, the FDA announced the five winners of the Veterans Cardiac Health and AI Model Predictions (V-CHAMPS) Challenge. A team of data scientists and clinicians from the FDA, Veterans Health Administration, and National Institute of Standards and Technology dual-anonymously judged the entries to select the winners based on performance of model predictions when tested with real-world data. The V-CHAMPS Challenge intends to encourage the development of artificial intelligence and machine learning (AI/ML) models to predict heart failure related outcomes – including hospitalization, readmission, and mortality. The models use artificially generated health records, for example, from real health record datasets with sensitive information replaced with phantom data to preserve patient privacy.
On Tuesday, the FDA published a Digital Health Center of Excellence blog titled “Digital Health Collaboration Fosters Innovation and Health Equity,” which includes a reminder to submit comments now through January 31, 2024, on how digital health technologies may help with early detection of risk factors for type 2 diabetes, prediabetes, and type 2 undiagnosed diabetes.
On Tuesday, the FDA published the FDA Voices: “FDA Approves Many New Drugs in 2023 that Will Benefit Patients and Consumers,” by Patrizia Cavazzoni, M.D., Director, Center for Drug Research and Evaluation. In 2023, CDER approved 55 novel drugs, as detailed in the annual New Drug Therapy Approvals report. The active ingredient(s) in a novel drug have not been previously FDA-approved. The FDA also took other important actions, such as expanding the indications or patient populations of some previously approved therapies. In addition, the agency approved new dosage forms or drug formulations and made some prescription drugs available over-the-counter.

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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.