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FDA “Data Steward” Role Suggested By Industry In Lieu of Direct Release of NDA/BLAs

This article was originally published in RPM Report

Executive Summary

FDA surprised a number of industry observers in June when the agency interpreted a call for “regulatory science” improvements from FDASIA to include release of NDA and BLA data. Instead of just objecting outright to the proposal, however, a number of biopharma groups have suggested other ways in which FDA can mine useful information from the dataset through collaborative relationships.

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