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# Drug Labeling for Accelerated Approval Products
- URL: https://www.fdaweb.com/drug-labeling-for-accelerated-approval-products/
- Published: 2019-02-05T12:00:00.000Z
- Updated: 2026-09-15T01:00:31.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143301

*Federal Register* notice: FDA has issued a guidance entitled *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 products approved under the accelerated approval regulatory pathway. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM390058.pdf?ref=fdaweb.com) focuses on indications for drugs approved on the basis of a surrogate endpoint or a clinical endpoint other than survival or irreversible morbidity. It 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. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-02-04/pdf/2019-00894.pdf?ref=fdaweb.com).