# Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information – FDA Guidance

Source: https://www.keypedia.com/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.

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## 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: <a href="https://www.regulations.gov/docket/FDA-2007-D-0302 ">FDA-2007-D-0302 </a>

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