> ## 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.

# FDA Guide on Drug Starting Materials
- URL: https://www.fdaweb.com/fda-guide-on-drug-starting-materials/
- Published: 2018-02-26T12:00:00.000Z
- Updated: 2026-09-14T23:25:23.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140842

*Federal Register* notice: FDA has made available a guidance on “Q11 Development and Manufacture of Drug Substances — Questions and Answers (Chemical Entities and Biotechnological/Biological Entities).” The document, which was prepared under the direction of the International Council for Harmonization (ICH), includes questions and answers that were developed to clarify the principles for selecting starting materials described in the ICH guidance “Q11 Development and Manufacture of Drug Substances.” It focuses on chemical entity drug substances, and provides recommendations on the information that should be provided in marketing authorization applications and master files to justify the starting materials. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-02-26/pdf/2018-03809.pdf?ref=fdaweb.com).