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Data Standards: Technical ‘Postmortem’ Could Clarify US FDA Preferences, Industry Says

 
• By Sue Sutter

Feedback on application-specific data submission issues that vexed the agency but were not onerous enough to warrant a refuse-to-file letter would help inform future filings and reduce variation across sponsors, industry representatives say at meeting on analytical data standards.  

scientist working with laptop in lab / biomedical engineering working with computer in laboratory - Image
FDA is seeing wide variation in how sponsors are interpreting data submission standards. • Source: Shutterstock

Biopharma sponsors want more feedback from the US Food and Drug Administration on what they are doing right and wrong when it comes to the technical aspects of data submissions.

More clarity about how the agency prefers data to be structured and formatted could better aid the agency’s review activities by reducing the variation in practices across sponsors. It also...

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