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‘Accelerated approval’ drugs: How well are they studied?

‘Accelerated approval’ drugs: How well are they studied?

When an investigational prescription drug shows promise for treating a serious illness or filling an unmet medical need, the Food and Drug Administration (FDA) has special programs available to expedite its clinical testing and approval. One is the “Accelerated Approval” pathway, in which the FDA will accept weaker-than-usual evidence of the drug’s efficacy from its […]