FDA Oncology Center Signals ‘Tough’ Approach On Confirmatory Trials

By Jessica Karins / November 17, 2023 at 12:43 PM
FDA plans to start cracking down on companies that do not complete timely confirmatory trials for products granted accelerated approvals and may start pulling drugs from the market, or denying accelerated approval to companies that do not already have a confirmatory trial underway, officials with the agency’s cancer drug center said this week ahead of a meeting on two drugs that have been delinquent in completing confirmatory trials for over nine years. Richard Pazdur, the director of FDA’s Oncology Center...

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