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Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change that
Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their ...
White House readies nicotine proposal in administration’s final days
Click in for more news from The Hill{beacon} Health Care Health Care   The Big Story FDA rule to lower nicotine levels closes ...
FDA limits toxic lead in some baby foods
The U.S. Food and Drug Administration on Monday set maximum levels for lead in baby foods like jarred fruits and vegetables, ...
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FDA issues draft guidance for AI-enabled devices
The FDA has released draft guidance for developers of AI-enabled medical devices, offering recommendations aimed at ensuring the safety and effectiveness of the devices.
Can eggs spread bird flu? What you must know
The spread of avian influenza (HPAI) has also impacted the nationwide supply of poultry products, including eggs. Experts ...
GSK and Pfizer's RSV vaccines to carry warnings of neurological disorder risk
GSK and Pfizer's respiratory syncytial virus (RSV) vaccines will carry warnings that they can increase the risk of developing ...
Health advocates are unhappy with FDA guidance on lead levels in baby food
The U.S. Food and Drug Association (FDA) released the first-ever guidelines for levels of lead in processed baby foods this ...
Solid Biosciences's IND For Gene Therapy To Treat Friedreich's Ataxia Gets FDA Clearance
SGT-212 is the company's novel, AAV-based FA gene therapy candidate designed to deliver full-length frataxin via systemic intravenous (IV) infusion as well as direct intradentate nuclei (IDN) infusion ...
Cat food recalled due to Salmonella contamination: Here’s what to know
The food was packaged in clear plastic and sold primarily in retail stores in Virginia, Maryland, Pennsylvania, Connecticut, Massachusetts, and New York.
Solid Biosciences Gains FDA Clearance for New Drug Application
Solid Biosciences received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday.
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FDA issues draft guidance on marketing submissions for AI-enabled medical devices
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...
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Extended telemental health flexibilities ‘still far from an ideal outcome’
Congress recently extended Medicare telehealth flexibilities that waive a requirement for an in-person visit before a patient ...