FDA Issues Draft Guidance on Labeling for Drugs Approved Under Accelerated Regulatory Pathway

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 03-26-2014 09:10


FDA has issued draft guidance, Guidance for Industry: Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway, to assist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 for indications that are approved under the accelerated approval regulatory pathway as defined in Section 506(c) of the Federal Food, Drug and Cosmetic Act and 21 CFR Part 314, Subpart H or 21 CFR Part 601, Subpart E.

Specifically, the guidance focuses on indications and usage statements for drugs approved on the basis of a surrogate endpoint or an effect on 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 under 21 CFR 314.460 or 21 CFR 601.46 or when FDA withdraws accelerated approval of an indication while other indications for the drug remain approved.

Source: FDA









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