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After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820...
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On January 21, 2024, the FDA issued a final rule amending its Quality System (QS) regulations under 21 CFR Part 820, which addresses current good…
In 1973, Sir Elton John sang, “Harmony and me, we’re pretty good company,” on his classic album, Goodbye Yellow Brick Road. More than 50 years later, the Food and Drug Administration...
On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule amending the device good manufacturing practice (GMP) requirements of the Quality System...