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 ...
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 ...
On February 2, 2026, FDA’s new Quality Management System Regulation (“QMSR”) for medical devices became effective, two years after FDA’s issuance of a final rule to implement the QMSR. The QMSR ...
In this free webinar, see how audit readiness can be strengthened as the FDA transitions from QSIT to QMSR. Attendees will learn about the implications of the shift from inspection-based QSIT to a ...
The FDA slammed ExThera with a warning letter for deviating from the regulatory agency’s guidelines by promoting and selling ...
Discover the latest stocks recommended by top Wall Street analysts, all in one place with Analyst Top Stocks Make smarter investments with weekly expert stock picks from the Smart Investor Newsletter ...
On Monday, February 2, a new final rule from FDA changing QMS requirements for medical devices went into effect. Manufacturers have had over two years to comply with the new rule, which is now full ...
The Food and Drug Administration released two documents Tuesday following inspections of Palo Alto, Calif.-based Theranos. Here are five things to know about the latest in the Theranos saga — the ...
FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed on Oct. 14, 2015. (AP Photo/Andrew Harnik, File) (Andrew Harnik, Copyright ...
WASHINGTON (AP) — The Trump administration’s effort to slash the size of the federal workforce reached the Food and Drug Administration this weekend, as recently hired employees who review the safety ...
The Food and Drug Administration warning letter detailed unreported hypoglycemic episodes and a software change to correct ...
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