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# Draft Guide on Drug Starting Materials
- URL: https://www.fdaweb.com/draft-guide-on-drug-starting-materials/
- Published: 2017-02-21T12:00:00.000Z
- Updated: 2026-09-14T22:07:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5138026

*Federal Register* Notice: FDA has made available a draft guidance entitled “Q11 Development and Manufacture of Drug Substances — Questions and Answers (regarding the selection and justification of starting materials).” The International Council for Harmonization guidance is intended to clarify the principles for selecting starting materials. It focuses on chemical entity drug substances, and provides recommendation on the information that should be provided in marketing authorization applications and Master Files to justify the starting materials. To view the guidance, click [here](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM542176.pdf?ref=fdaweb.com). To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-02-21/pdf/2017-03309.pdf?ref=fdaweb.com).