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Watch now (31 mins) | We explore new FDA requirements for bioresearch monitoring electronic submissions, examine mandatory device shortage reporting, and analyze recent warning letters across multiple device firms.
The FDA's Center for Drug Evaluation and Research (CDER) just released its tenth annual "Drug Safety Priorities" report for fiscal year 2024 (ending September 30). While labeled as "priorities," it's essentially a comprehensive year-in-revi...
Yesterday, Judge Sean D. Jordan of the District Court for the Eastern District of Texas heard oral argument in the consolidated suits against the FDA regarding the final rule to regulate laboratory-developed tests as medical devices.
Manufacturing facilities in India, Texas, and Florida demonstrate how fundamental quality issues continue to plague both domestic and international pharma operations.
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