FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
JD Supra4m
JPM2025: Regulation of artificial intelligence: Navigating a new frontier in health care
Artificial intelligence (AI) is transforming the health care landscape, from diagnostics to drug development and clinical trials. As AI ...
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The FDA published its first draft guidance on the use of AI in the development of drugs and biological products ...
JD Supra35m
MoCRA Guidance Update for Registration and Listing of Cosmetic Product Facilities and Products
What Happened: The Food and Drug Administration (FDA) released new guidance regarding the registration and listing of ...
FDA issues draft guidance on developing weight loss drugs
The U.S. FDA has released a new draft guidance for drugmakers to aid them in developing new treatments for obesity.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 ...
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 ...
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, ...
New FDA guidance aims to improve accuracy of pulse oximeters for people of color
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
FiercePharma22h
FDA looks to clarify confirmatory trial mandate for accelerated approvals
In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory ...
STAT22h
FDA’s new guidance on AI in drug development centers the risk introduced by the technology
After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
FDA revises limit on lead in some baby food; Here’s what to know
The US FDA has issued guidance to limit lead levels in processed baby foods, aiming to reduce exposure by 20%-30%.
FDA recommends more robust testing of pulse oximeters to avoid bias in people with dark skin tone
New draft guidelines would increase the number of people with darker skin who should be included in clinical trials of the ...