FDA: New ICH guidance for industry for Development and Manufacture of Drug Substances Q&A
Murilo Freitas - 13:23, 23 de febrero de 2018853
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FDA released a guidance for industry entitled “Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers.” This guidance is intended to provide clarification to the International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidance document “Q11 Development and Manufacture of Drug Substances” to improve harmonization and promote convergence for information that should be provided in marketing authorization applications and Master