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Accelerated Approval Withdrawals Through The Years

Executive Summary

Lartruvo’s brief time on the market is especially quick compared with other drugs and indications that received accelerated approval from the US FDA and were subsequently withdrawn, our infographic shows.

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Company cites comments by Oncology Center of Excellence Director Richard Pazdur and Office of Neuroscience Director Billy Dunn on reasons why confirmatory trials fail and the need for regulatory flexibility. Ironically, both senior officials have publicly extracted commitments from companies to withdraw products if postmarketing trials do not verify clinical benefit.

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