FDA guidance: Labeling for human prescription drug under accelerated approval regulatory pathway

New FDA guidance, which is intended to assist applicants in developing the INDICATIONS AND USAGE section of labeling for human prescription drug and biological products has been issued.

This is for drugs 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. More specifically, this guidance focuses on indications for drugs approved via accelerated approval on the basis of a surrogate endpoint or a clinical endpoint other than survival or irreversible morbidity. This guidance also addresses labeling considerations for indications that were approved under accelerated approval and for which clinical benefit subsequently has been verified and the FDA terminates the conditions of accelerated approval under 21 CFR 314.560 or 21 CFR 601.46. In addition, this guidance addresses labeling considerations when the FDA withdraws approval of an indication that had been approved through the accelerated approval pathway while other indications for the drug remain approved.

See: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM390058.pdf

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology