FDA “JumpStart” Data Service Gives Reviewers Leg Up On Complex NDAs
This article was originally published in RPM Report
FDA is looking for ways to make the review process more efficient, especially as biopharma applications become more data-heavy and complex. One new time-saving review tool at FDA, JumpStart, “partitions” the work on an NDA or BLA by asking data experts in the Office of Computational Science to run initial analyses and flag areas for follow up by the review teams. It’s been a big hit in the Office of New Drugs.
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“JumpStart” analytics service provides data fitness assessments and exploratory safety analyses to clinical reviewers within two weeks following NDA/BLA submission.
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