Accelerated Approval: US FDA Defends Size Of Premarket Safety Databases, Confirmatory Endpoints
Taking on critics who say it is too quick to award accelerated approval based on surrogate endpoints and limited safety data, agency's 25-year review shows cancer drugs receiving accelerated approval generally have twice the amount of safety data as efficacy, and more than half have confirmed clinical benefit after approval.
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Over 30-year period, approvals increasingly used expedited programs and were based on fewer pivotal trials with less robust comparators, authors report.
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