Historically, the FDA has notified drug manufacturers outside of the United States of drug inspections weeks or even months ahead of time. The Senate Committee on Finance believes this gives foreign drug facilities ample time to correct or conceal noncompliance. However, U.S.-based drug manufacturers aren’t afforded the luxury of pre-announced inspections. According to a recent SIDLEY article, a newly introduced bill wants to eliminate the delay between notice and inspection for manufacturers abroad.
New Bill Wants to Do Away with Advance Notice for Foreign Drug Inspections
The proposed bill aims to level the playing field between domestic and foreign surveillance inspections.
Feb 7, 2022
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