Drug Review Times Are Not Shortened Much By Single Expedited Review Designation
Government Accountability Office also finds that US FDA review divisions are largely consistent in their assessment times after controlling for goal dates and expedited programs.
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Pivotal Studies Supporting US FDA Drug Approvals Have Declined, JAMA Research Finds
Over 30-year period, approvals increasingly used expedited programs and were based on fewer pivotal trials with less robust comparators, authors report.
CDER’s Woodcock On COVID-19: Missed User Fees Unlikely, But Some Work Will Be ‘Set Aside’
In a podcast interview, Janet Woodcock talks about review deadlines, prioritizing pre-approval inspections, and how advisory committees could be held in an era of social distancing.
US FDA Drug Office Reorg Enters Homestretch With Leadership Nods For Three Clinical Offices
Hylton Joffe was named acting director of the new Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine but also will continue to serve as Office of New Drugs acting deputy director; agency veterans Ellis Unger and Julie Beitz also tapped for clinical office leadership roles in final stage of massive reorg.