# Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/labeling-for-human-prescription-drug-and-biological-products-approved-under-the-accelerated-approval-regulatory-pathway/53afccba-4a69-4547-878f-b1a1b9a1e7b9 > FDA guidance document: Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway. Issue date: February 04, 2019. Get complete insights and analysis. --- ## Details - Title: Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway - Communication Type: Guidance Document - Product Type: drugs - Office Name: Center for Drug Evaluation and Research - Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c - Issue Date: 2019-02-04 - Last Changed: 2020-04-24 - Docket Number: FDA-2014-D-0250 ## Related Documents - [QTc Information in Human Prescription Drug and Biological Product Labeling: Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/qtc-information-in-human-prescription-drug-and-biological-product-labeling-guidance-for-industry/84e1bfb1-3a7d-4f4f-ad99-9da85ee92408) - [Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice](https://www.globalkeysolutions.net/guidances/guidance-document/pediatric-information-incorporated-into-human-prescription-drug-and-biological-products-labeling-good-review-practice/b745efcc-5e41-4458-a1d9-6827d55dd3a7) - [Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products: Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/enrichment-strategies-for-clinical-trials-to-support-approval-of-human-drugs-and-biological-products-guidance-for-industry/7a080f34-cb3a-4789-b96a-a16fd0b0e9ef)