> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Guide on ANDA Info Requests/Review Letters
- URL: https://www.fdaweb.com/guide-on-anda-info-requests-review-letters/
- Published: 2022-01-27T12:00:00.000Z
- Updated: 2026-09-14T17:30:21.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151017

*Federal Register* notice: FDA is making available a final guidance entitled “Information Requests and Discipline Review Letters Under GDUFA.” The document explains how FDA will issue and use an information request and discipline review letter during the assessment of an original ANDA. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-01-27/pdf/2022-01605.pdf?ref=fdaweb.com).