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Data Integrity: US FDA Guidance Seeks To Head Off Bioavailability/Bioequivalence Study Problems

 
• By Sue Sutter

Ultimate responsibility for data integrity rests with applicant, even if study is contracted out; testing site management should build a culture of quality, says the guidance, which aims to address the high-profile data integrity problems that have plagued the generic drug industry.

Drawing bullseye
A new guidance takes aim at the data integrity problems that have plagued industry in recent years. • Source: Shutterstock

A new US Food and Drug Administration guidance takes aim at heading off a high-profile problem that has troubled the generic drug industry in recent years – fraud and other data integrity issues with bioavailability and bioequivalence studies.

Recommendations in the draft

Key Takeaways

  • FDA’s new draft guidance is aimed at heading off the types of data integrity concerns with BA/BE studies seen during inspections and drug application assessments.

  • The guidance makes clear that the ultimate responsibility for data integrity rests with the applicant, even if the study is contracted out

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