FDA Finalizes Guidance on Labeling for Accelerated Approval Drugs

January 30, 2019

The FDA released final guidance for sponsors on the indications and usage labeling section of drugs on the agency’s accelerated approval pathway.

The guidance specifically deals with drug indications that receive accelerated approval based on a surrogate or intermediate clinical endpoint other than survival or irreversible morbidity, including indications withdrawn by the agency under the pathway while other indications for the drug remain approved.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,” FDA Commissioner Scott Gottlieb said.

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