FDA finalizes accelerated approval labeling guidance
The FDA on Tuesday finalized guidance on labeling drugs and biologics approved under the accelerated approval pathway.
The FDA’s accelerated approval program allows the agency to approve products to treat serious or life-threatening conditions based on surrogate or intermediate clinical endpoints “that are reasonably likely to predict clinical benefit.” When granting accelerated approval, FDA will require a sponsor to complete postmarketing studies to confirm the product’s benefits.
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