USA – FDA Finalizes Accelerated Approval Labeling Guidance

The US Food and Drug Administration (FDA) on Tuesday finalized guidance on labeling drugs and biologics approved under the accelerated approval pathway.

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.

The nine-page guidance finalizes a draft version released for comment in 2014 and focuses on the Indications and Usage section of labeling for products granted accelerated approval based on a surrogate endpoint or a clinical endpoint other than survival or irreversible morbidity.

The guidance also provides labeling recommendations for products granted accelerated approval that have subsequently had their clinical benefit confirmed, as well as labeling considerations for products that have had an indication with accelerated approval withdrawn while other indications for the same product remain approved.

« To make sure this pathway remains robust, we’re taking new steps to help ensure that a product’s labeling provides actionable and complete information about the clinical evidence supporting an accelerated approval and clearly states that post-market commitments may have to be met for an indication to remain approved, » said FDA Commissioner Scott Gottlieb…