Q11 Development and Manufacture of Drug Substances-Questions and Answers (Chemical Entities and Biotechnological/Biological Entities); International Council for Harmonisation; Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled "Q11 Development and Manufacture of Drug Substances--Questions and Answers (Chemical Entities and Biotechnological/Biological Entities)." The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance consists of 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", published November 20, 2012. The guidance is intended to provide additional clarification and to promote convergence on the considerations for the selection and justification of starting materials. The questions and answers focus on chemical entity drug substances, and provide recommendations on the information that should be provided in marketing authorization applications and/or master files to justify the starting materials.