medtechdive11m
FDA aims to stem AI device bias, boost transparency in draft guidance
The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...
healthday28m
FDA Calls for Better Accuracy of Pulse Oximeters in People of Color
Pulse oximeters -- those tiny devices that measure blood oxygen levels with a quick clip to your finger -- may soon ge ...
FDA issues draft guidance on developing weight loss drugs
The U.S. FDA has released a new draft guidance for drugmakers to aid them in developing new treatments for obesity. The new ...
JD Supra1h
Clinical Trial Protocol Deviations: A New FDA Draft Guidance to Ring in the New Year
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review ...
MedPage Today1h
FDA Limits Toxic Lead in Some Baby Foods
The agency issued final guidance that it estimated could reduce lead exposure from processed baby foods by about 20% to 30%.
Southeast Missourian1h
Junk food, drug use cut into life expectancy gains across U.S.
A new study reveals that junk food and drug use are hindering life expectancy gains in the U.S., despite technological ...
MedPage Today1h
FDA Unveils Draft Guidance to Improve Pulse Oximeter Accuracy Across Skin Tones
The FDA recommendations apply to only professional oximeters used in hospitals, doctor's offices, and other medical settings.
JD Supra2h
FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities
On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...
BioSpace2h
When Are Confirmatory Trials ‘Underway’? FDA Releases New Accelerated Approval Guidance
Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for ...
STAT3h
Pharmalittle: We’re reading about FDA guidance on AI, meds releasing ‘forever chemicals,’ and more
The FDA published its first draft guidance on the use of AI in the development of drugs and biological products ...
BioSpace4h
FDA’s New AI Guidance Highlights Risks of Technology, Urges Early Sponsor Engagement
The FDA’s guidance on AI in drug development points to potentially life-threatening consequences of the technology, ...
FDA limits toxic lead in some baby foods – here's what to know
The FDA has set maximum levels for lead in packaged processed foods sold in jars, pouches, tubs or boxes. Here's what to know ...