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FDA, Dr Marty Makary

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 · 1d
FDA proposes new system for approving customized drugs and therapies for rare diseases
The FDA guidelines aim to create a new pathway for bespoke therapies due to the challenges of conducting large studies.

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The American Journal of Managed Care · 5d
FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process
Clinical Trials Arena on MSN · 4d
FDA to allow one pivotal trial instead of two for drug approval
Fierce Biotech
1d

FDA illuminates new approval pathway for bespoke gene editing therapies

After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...
PharmExec
5d

FDA Removes Two Study Requirement for New Drug Approval Process: Report

FDA Will Drop Two-Study Requirement for New Drug Approvals, Aiming to Speed Access U.S News February 18, 2026 ...

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