JD Supra1h
FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on ...
JD Supra1d
FDA Issues Detailed Guidance for Biopharma Industry on What Information to Provide to FDA About Use of AI Models
On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use ...
Red 3 Ban: Other Ingredients That Could Now Face FDA Scrutiny
Yellow No. 5 is commonly used in brightly colored soda and candy, often to make them appear fresher and more appetizing.
Medscape10h
New Hidradenitis Suppurativa Guidelines Focus on Special Patient Populations
The guidelines are a first-of-its-kind effort to establish recommendations for the medical management of HS in seven ...
Food Safety News2d
FDA announces new strategy to prevent contamination of fresh and frozen berries
Two industry groups applauded the FDA’s new program. The American Frozen Food Institute (AFFI) said the release of the new prevention strategy aligns closely with AFFI-published guidance and ...
Motherly on MSN11d
The FDA sets new lead limits in baby food—but is it enough to protect babies?
The FDA’s new action levels set the following limits on lead content in processed foods for babies and young children: 1 0 ...
Healio9d
FDA releases draft guidance on pulse oximeter study recommendations
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
TCTMD13d
FDA Issues Draft Guidance for Improving Skin Tone Disparities of Pulse Oximeters
The agency is proposing that device manufacturers improve their testing to including larger, more diverse sample sizes.
New FDA proposal would put 'front-of-package' nutrition labels on food products
The U.S. Food and Drug Administration hopes "front-of-package" labeling will better improve the American population's health, ...
Outgoing FDA chief flags online weight loss drug dangers
Current laws and regulations are not enough to protect Americans from the risks of compounded versions of popular weight loss ...
infectiousdiseaseadvisor.com13d
Advocates Say FDA Guidance on Lead Levels in Baby Food Is Insufficient
Advocates are criticizing the United States Food and Drug Administration's guidelines on lead in baby food, arguing that the limits are too lenient and fail to protect children from harmful exposure ...
MedPage Today12d
Future of Lab-Developed Tests Still Taking Shape
Opens in a new tab or window As the new Congress and a new administration start up, the fate of FDA-issued regulations on laboratory-developed tests (LDTs) is one of many issues that health ...