News
Pink Sheet – Time To Simplify US FDA’s Expedited Pathways? It Won’t Be Simple
September 27, 2021
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Pink Sheet – Picture Is Worth 1,000 Meetings: ‘Snapshots’ Could Support ‘Breakthrough’ Dialogue At US FDA
September 27, 2021
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NPR – The FDA Has Been Without A Permanent Leader For 8 Months As COVID Cases Climb
September 22, 2021
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Pink Sheet – Accelerated Approval: US FDA Wants Comprehensive Development Plan From Oncology Sponsors
September 21, 2021
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Endpoints News – When efficacy is borderline: FDA needs to get more consistent on close-call drug approvals, agency-funded research finds
September 21, 2021
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The New England Journal of Medicine – Treatment of Older Adults with Cancer — Addressing Gaps in Evidence
September 16, 2021
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Regulatory Focus – Groups suggest changes to FDA’s guidance expanding eligibility criteria for oncology trials
August 27, 2021
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STAT News – Will controversy over new Alzheimer’s drug spell the end for the FDA’s faster approval process?
August 10, 2021
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Pink Sheet – FDA’s Pazdur Believes ‘Advanced Research’ Project Could Address Trial ‘Wastefulness’
August 2, 2021
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Regulatory Focus – Pazdur mounts defense of accelerated approval during Cures 2.0 panel
July 30, 2021
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Pink Sheet – FDA’s Pazdur: Accelerated Approval Is ‘Under Attack,' Supporters Can’t Afford To Remain Silent
July 29, 2021