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FDA Publishes Draft Guidance on Test Validation, Submission for EUAs
FDA officials said that the draft guidance is meant to address recommendations from two reports on the agency's response to COVID-19.
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 ...
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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
STAT19h
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After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
STAT20h
FDA releases long-awaited guidance to improve accuracy of pulse oximeters for all skin tones
Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should either ...
Quality Assurance21h
FDA Releases Allergen, Food Safety and Plant-Based Alternative Labeling Guidance
The four new guidance documents are designed to help industry and other interest holders understand and comply with FDA ...
FDA issues first draft guidance on use of AI in drug, medical device development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 ...
Modern Healthcare22h
FDA drafts guidance for AI developers
The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of ...
Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease
Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025Cyprium is eligible to receive royalties and up to $129 ...
Cosmetics Business5d
FDA proposes standardised asbestos detecting in cosmetics containing talc
A proposed rule would require makers of talc-containing cosmetic products to test for asbestos via an analytical approach ...