# Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/labeling-for-human-prescription-drug-and-biological-products-determining-established-pharmacologic-class-for-use-in-the-highlights-of-prescribing-information/40f1843c-d877-44dc-814b-63c7e743d168 > FDA guidance document: Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information. Issue date: October 19, 2009. Get complete insights and analysis. --- ## Details - Title: Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information - 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: 2009-10-19 - Last Changed: 2020-04-24 - Docket Number: FDA-2007-D-0302 ## Related Documents - [Acute Bacterial Sinusitis — Developing Antimicrobial Drugs for Treatment](https://www.globalkeysolutions.net/guidances/guidance-document/acute-bacterial-sinusitis-developing-antimicrobial-drugs-for-treatment/5e420779-6391-4202-a6d4-a6ba2b0a325d) - [Irritable Bowel Syndrome -- Clinical Evaluation of Products for Treatment](https://www.globalkeysolutions.net/guidances/guidance-document/irritable-bowel-syndrome-clinical-evaluation-of-products-for-treatment/35ac3629-54d7-4373-91dd-08aadc8f7489) - [Guidance for Industry Acute Bacterial Sinusitis: Developing Drugs for Treatment](https://www.globalkeysolutions.net/guidances/guidance-document/guidance-for-industry-acute-bacterial-sinusitis-developing-drugs-for-treatment/7da00031-ea5b-4089-9e6f-f3d05d4121bd)