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July 25, 2022 – NPR found that 42% of currently outstanding confirmatory studies – or 50 of them – either took more than a year to begin following accelerated approval or hadn’t started at all. Nineteen of those required studies still haven’t started three years or more after accelerated approval. Four of them haven’t started more than 10 years later. That means many drugs that made it to market with an accelerated approval are being used – sometimes for years – without patients, doctors or regulators knowing if they really work.

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