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# Orange Book Questions and Answers Guide
- URL: https://www.fdaweb.com/orange-book-questions-and-answers-guide/
- Published: 2020-06-01T12:00:00.000Z
- Updated: 2026-09-14T16:16:38.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146897

*Federal Register* notice: FDA has made available a draft guidance entitled “Orange Book — Questions and Answers.” The document provides answers to commonly asked questions FDA has received from interested parties about the *Orange Book*. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-06-01/pdf/2020-11682.pdf?ref=fdaweb.com).