New Accelerated Approval Withdrawal Process More Streamlined, Marks Says

OCE Director Richard Pazdur was less sanguine, however, noting that while the Pepaxto withdrawal may have been faster than others, it still required more than 60 meetings to complete.

multiple myeloma
Pepaxto is the third product that used accelerated approval to gain market entry and then be withdrawn through FDA regulation. • Source: Shutterstock

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