FDA: Draft Guidance: Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway

This guidance is intended to assist applicants in developing the INDICATIONS AND USAGE section of labeling for human prescription drug and biological products for indications that are approved under the accelerated approval regulatory pathway (hereafter accelerated approval) as defined in section 506(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 314, subpart H, or 21 CFR part 601, subpart E.