On Sept. 29, 2023, I fell asleep — certain that the government would shutdown at midnight the next day. The threat was real. The Alliance for a Stronger FDA had already circulated a shutdown toolkit ...

Watch this critical discussion on how regulators and biotech companies can bridge the expectation gap during the regulatory ...

For more information, or to register for this event, visit Leverage Cognitive Data to Improve Sleep-Wakefulness Drug ...

In this free webinar, see how audit readiness can be strengthened as the FDA transitions from QSIT to QMSR. Attendees will learn about the implications of the shift from inspection-based QSIT to a ...

The reorganization of the Food and Drug Administration’s human foods programs was urgently needed and a long-time coming. The full plan still needs to go through review by Office of Management and ...

As clinical development grows increasingly complex, the industry has recognized the critical role of centralized processes and risk‑based monitoring in ensuring high‑quality, reliable data. Regulatory ...