The FDA recently updated the definition of "healthy" on food labels. The change reflects updates in nutrition science since ...
In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the ...
Integra Lifesciences recently received an FDA warning letter pertaining to quality systems issues at several facilities.
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: ...
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...
In a warning letter posted online late last month, the FDA scolded Viatris over a range of production slights at the ...
The FDA stated that the Kirkland recall was related to quality control issues, noting in the official recall that the "released product should have been rejected." This was a Class II recall ...
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