Accelerated approval: unfulfilled promises for FDA’s expedited review program ...Middle East

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Accelerated approval: unfulfilled promises for FDA’s expedited review program
As practicing physicians, approval by the U.S. Food and Drug Administration (FDA) reassures us that the treatments we prescribe our patients have been rigorously vetted as effective and safe. For a growing number of drugs, however, FDA approval comes with lingering uncertainty of their benefit. Under the accelerated approval pathway, FDA provisionally approves drugs based on surrogate endpoints, such as laboratory or imaging results that are proxies for disease progression, with the requirement that manufacturers conduct clinical trials following approval to confirm clinical benefit. This arrangement is intended to speed access to promising treatments, with the expectation that manufactur

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