In Part 2 of its 2024 review, C-realize continues to shed light on US Food and Drug Administration (FDA) and European Medicines Agency (EMA) oversight actions.

The FDA slammed Applied Therapeutics with a December warning letter over data integrity lapses in clinical trials, while Sichuan Deebio faced scrutiny for current good manufacturing practice (cGMP) deviations in active pharmaceutical ingredient (API) production. Meanwhile, the EMA issued GDP non-compliance reports to Romanian firms like An-Ra SRL for weak quality systems and traceability failures. These cases highlight the regulators’ focus on Good Manufacturing and Distribution Practices, along with data integrity.

Want the full scoop on these critical enforcement actions? Read more here.