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Nielsen Hobbs

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Takoma Park
As seen in: The Pink Sheet, Citeline, Generics Bulletin, Medtech Insight, Scrip, AIS Health, The Pink Sheet Podcast
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Articles

Pink Sheet Podcast: US FDA’s New Guidance On One-Trial Efficacy Standard And IND Reform Pilot

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By Derrick Gingery Verified, Maaisha Osman Verified, Nielsen Hobbs Verified
| The Pink Sheet Podcast
Pink Sheet reporter and editors discuss the FDA’s draft guidance outlining its one-trial plus confirmatory evidence standard for effectiveness and a new pilot program to speed IND clearances.
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US FDA Moves To Collapse 25 Submission Portals Into One As AI Reshapes Reviewer Workflow

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By Nielsen Hobbs Verified
| The Pink Sheet Verified
The FDA’s IT overhaul has cut software costs, sped FAERS data to a daily refresh and folded seven safety systems into one, even as officials warn industry they can spot AI-generated protocols. DIA Annual Meeting The FDA's acting CIO said the agency's "ability of technology is outpacing our ability to use it," with Elsa 4.0 now wired directly into review data.
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US FDA Leadership Pledges ‘Reset’ With Rare Disease Sponsors As uniQure BLA Nears Filing

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By Nielsen Hobbs Verified
| The Pink Sheet Verified
Officials signaled openness to external controls, intermediate clinical endpoints and a single pivotal study, while maintaining that the effectiveness standard is unchanged, just as the FDA reversed course and accepted a Phase I/II analysis for a Huntington's gene therapy BLA filing. DIA Annual Meeting After numerous disputes with rare disease sponsors, the FDA is hitting the reset button.
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