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 ...
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 ...
During the initial phase of the COVID-19 pandemic, the Food and Drug Administration (FDA) halted inspections of most overseas drug manufacturing establishments. Looking at data from the period 2012–22 ...
May 6 (UPI) --The U.S. Food and Drug Administration said Tuesday it will expand its use of unannounced inspections at foreign manufacturing facilities. "For too long, foreign companies have enjoyed a ...
The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.
Borescopic visual inspection may be appropriate for small parts with areas not visible to the naked eye. Even with all the high-tech testing and inspection techniques in use today, basic visual ...
Sens. Johnny Isakson (R-GA) and Michael Bennett (D-CO) have introduced a bill that looks dramatically alter the US Food and Drug Administration's (FDA) process for inspecting device manufacturers.
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