A senior US Food and Drug Administration official urged manufacturers to look for tell-tale “anomalies” in data from their contract research organizations given the serious downstream repercussions that could follow a data integrity problem.
Key Takeaways
-
“Data Integrity for In Vivo Bioavailability and Bioequivalence Studies” is already the subject of a draft guidance, but FDA officials are directly urging industry to take the issue seriously.
-
When reviewing CRO data, look for PK profiles that are “too similar, or the same as the next one,” CDER Director Patrizia Cavazzoni advised sponsors
While addressing the recent Global Pharmaceutical Quality Summit in Mumbai, Patrizia Cavazzoni, director of the US FDA's Center for Drug Evaluation and Research (CDER), minced no words referring to a “very concerning trend” with data integrity problems pertaining to
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Generics Bulletin for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?