Draft Guidance for Industry on Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway; Availability

Resumo

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway." This draft guidance discusses FDA's recommendations for developing the indication and usage statements in the prescribing information for drugs approved under the accelerated approval regulatory pathway (hereafter "accelerated approval"). The guidance also discusses labeling considerations for indications approved under accelerated approval when clinical benefit has been verified and FDA terminates the conditions of accelerated approval, or when FDA withdraws accelerated approval of an indication while other indications for the drug remain approved.