Warning Letter Roundup & Recap – July 2022
A manufacturer and importer of COVID-19 tests was cited for distributing unauthorized devices as well as GMP violations in the only warning letter issued to a medtech company last month.
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Two Massachusetts-based infusion pump manufacturers with the same founder and CEO received warning letters from the US FDA for similar violations.
More rolling reviews, a reduction in review rounds, and a rise in applications through two international regulatory collaboration initiatives were among the factors behind a reduction in new drug authorization times in Switzerland last year. However, “submission gaps” versus other regulators remain a problem.
The Paris-headquartered company has thrown in the towel on its oral SERD, leaving Roche, Eli Lilly and AstraZeneca to pursue Menarini in the field.