federal_register: 2011-16255

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2011-16255 International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of Drug Substances; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Q11 Development and Manufacture of Drug Substances." The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes approaches to developing process and drug substance understanding and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The draft guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities) to enable a consistent approach for providing and evaluating this information across the three regions. 2011-06-29 2011 6 https://www.federalregister.gov/documents/2011/06/29/2011-16255/international-conference-on-harmonisation-draft-guidance-on-q11-development-and-manufacture-of-drug https://www.govinfo.gov/content/pkg/FR-2011-06-29/pdf/2011-16255.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Q11 Development and Manufacture of Drug Substances." The draft guidance was prepared under the auspices of the International Conference on Harmonisation...  

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