Accelerated approval' drugs: How well are they studied?
World pharma news | August 16, 2017
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 pre-clinical trials. In exchange, the FDA requires that the manufacturer conduct post-approval confirmatory studies.