JD Supra9d
Navigating FDA from 2024 into 2025 Human Foods Program
FDA Restructures its Food Resources Although there were a number of significant new regulations, the most significant food ...
The American Journal of Managed Care5d
FDA Quietly Removes Draft Guidance on Diversity in Clinical Trials Following Executive Order on DEI
The FDA removed previously issued draft guidance on diversity in clinical trials from its website without public notice or ...
JD Supra14d
FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how ...
Healio24d
FDA releases draft guidance on pulse oximeter study recommendations
The FDA announced its draft ... The recently published draft guidance recommends the use of controlled desaturation laboratory studies for device analysis but also states that real-world data ...
The National Law Review28d
FDA Releases Draft Guidance for Low-Moisture Ready-to-Eat Foods
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up to receive our free e-Newsbulletins Some states have laws and ethical rules regarding solicitation and ...
STAT1mon
FDA’s new guidance on AI in drug development centers the risk introduced by the technology
The FDA’s new draft guidance comes on the heels of a reflection paper from the European Medicines Agency on the use of AI in the drug product lifecycle, finalized in September 2024.
policymed.com12d
Final FDA SIUU Guidance: Understanding the Key Updates and Resources
In the final days of the Biden Administration, the United States Food and Drug Administration (FDA) issued final guidance on ...
The Hill1mon
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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.
Seeking Alpha29d
FDA issues draft guidance on developing weight loss drugs
The U.S. FDA has released a new draft guidance for drugmakers to aid them in developing new treatments for obesity. The new document replaces an earlier draft guidance issued in February 2007.
CNN1mon
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
The FDA announced Monday that it has published draft guidance for manufacturers of pulse oximeters that offers recommendations for the clinical testing and labeling of these electronic medical ...
Healthcare Dive1mon
FDA issues much-anticipated guidance on pulse oximeters
The FDA first warned about problems with pulse oximeter accuracy in 2021. CDRH had listed draft guidance on pulse oximeters among its priorities for the 2024 fiscal year but missed the cutoff.
Seeking Alpha1mon
FDA issues first draft guidance on use of AI in drug, medical device development
Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released separate draft guidance on the use of the technology in the ...