FDA’s Pazdur: Accelerated Approval Is ‘Under Attack,' Supporters Can’t Afford To Remain Silent
US FDA’s Oncology Center of Excellence Director and the National Institutes of Health National Cancer Institute Director defended the agency’s accelerated approval pathway, saying critics are missing the benefits reaped by many cancer patients. Pazdur worries pathway is at risk, unless champions work to counter critics.
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US FDA cancer chief Rick Pazdur plans to send industry to ‘rehab’ with Project Frontrunner, which will push for development of cancer drugs in randomized controlled trials in earlier disease. Goal is to reduce time of uncertainty between accelerated approval and confirmatory evidence.
US FDA’s oncology chief says he won’t talk to sponsors unilaterally when a company takes issue with their review division. Pazdur also weighed in on his long-term career plans and his views on the FDA-industry revolving door at two ASCO interviews.
Even as the US FDA can expect to be put through the ringer with the congressional and HHS Inspector General probes, the process could have some upsides for the agency, according to former officials who have been through such scrutiny.