FDA Roundup: February 9, 2024

SILVER SPRING, Md., Feb. 9, 2024 /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Today, the FDA issued draft guidance for industry to provide recommendations for collecting representative samples for seafood products subject to Detention Without Physical Examination (DWPE) under an Import Alert because of the appearance of adulteration caused by pathogens, unlawful animal drugs, scombrotoxin (histamine), and/or decomposition. The draft guidance, once finalized, will help foreign manufacturers and other processors of seafood products subject to DWPE submit evidence to the FDA to support a request to have their products removed from DWPE.
On Thursday, the FDA issued an updated outbreak advisory for the Investigation of Listeria monocytogenes: Queso Fresco and Cotija Cheese. Three new recalls were added for products containing recalled dairy products from Rizo Lopez Foods, Inc. The advisory will continue to be updated as more information becomes available. More details about recalled products, including descriptions, sizes, and UPCs or “best by” dates are included in the table of recalled products.
On Wednesday, the FDA published a CDER From Our Perspective, where Sarah Ibrahim, PhD, Associate Director of Stakeholder and Global Engagement, CDER’s Office of Generic Drugs, discusses the implementation to date of the FDA and the European Medicines Agency’s (EMA) Parallel Scientific Advice pilot program focusing on complex generics/”hybrid medicines” (an EMA term for medications that loosely corresponds to complex generics). This voluntary pilot program facilitates concurrent discussions between generic drug applicants and the two regulatory bodies, with the ultimate goal of improving patient access to harder to develop generic drugs.
On Tuesday, the FDA authorized for marketing the Samsung Electronics Co., Ltd.’s Sleep Apnea Feature, a software-only, mobile medical application intended to detect signs of moderate-to-severe obstructive sleep apnea for adults 22 years of age and older who have not been diagnosed with sleep apnea. The Sleep Apnea Feature uses smart watch built-in sensors to monitor the user’s sleep for significant breathing disruptions associated with obstructive sleep apnea. The feature should not be used to replace traditional sleep apnea diagnosing methods such as a polysomnography. It is intended for over the counter and is currently compatible with the Samsung Galaxy Watch and Phone.

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.