Accelerated Approval Drug Labeling Guidance

FDA has issued a guidance, Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway, to assist applicants in developing the Indications and Usage section of labeling for human prescription drug and biological products approved under the accelerated approval regulatory pathway. More specifically, the document focuses on indications for drugs approved on the basis of a surrogate endpoint or a clinical endpoint other than survival or irreversible morbidity.

The guidance also addresses labeling considerations for indications that were approved under accelerated approval and for which clinical benefit subsequently has been verified and FDA terminates the conditions of accelerated approval. And it addresses labeling considerations when FDA withdraws approval of an indication that had been approved through the accelerated pathway while other indications for the drug remain approved.