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US FDA’s Cavazzoni To Manufacturers: Pay Attention To Data Received From CROs

 
• By Anju Ghangurde

Manufacturers should keep a sharp eye on data from contract research organizations, looking for “any irregularities” amid a concerning trend of data integrity issues pertaining to BA/BE studies conducted by certain CROs in India, the director of the FDA’s drug center says.

The FDA flags concerns about data integrity issues at CROs. • Source: Shutterstock

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  • “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies” is already the subject of a draft guidance, but FDA officials are directly urging industry to take the issue seriously.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

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