After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...
Dublin, Nov. 26, 2024 (GLOBE NEWSWIRE) -- The "Inspection and Audit Readiness Training for Medical Device Manufacturers-Live, Online Training" training has been added to ResearchAndMarkets.com's ...
In this month’s post, in the medical device realm I explore what kinds of inspection citations most often precede a warning letter. In this exercise, I do not try to prove causation. I am simply ...
Senators this week introduced a bipartisian bill that would update the Food and Drug Administration’s process for inspecting medical devices. The bill — sponsored by Sens. Michael Bennet, D-Colo., and ...
Traditionally, the FDA’s collaboration with foreign authorities has meant a fairly predictable rate of US FDA inspections for foreign medical device manufacturers selling their products in the US. But ...
A CMS report released Thursday with details from a federal inspection shows Palo Alto, Calif.-based Theranos’ proprietary blood-testing devices frequently missed the mark for accuracy on a range of ...
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