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 ...
The US Food and Drug Administration (FDA) on Tuesday finalized guidance formalizing a process for medical device makers to request nonbinding feedback on their proposed actions to address issues ...
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 ...
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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 ...
After years of discussion, the Food and Drug Administration may shift responsibility for routine food safety inspection to the states. While industry and food safety experts say it's a logical move, ...
Risk management is a major emphasis of FDA’s new compliance program, the Quality Management System Regulation (QMSR), and companies should expect to see big differences in how the agency will conduct ...
Foreign facilities failed FDA GMP inspections at up to 1.8x the U.S. rate. Journal of Pharmaceutical Innovation study quantifies a decade of oversight gaps. We first need rigorous, replicable ways to ...
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