federal_register: E7-17709

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E7-17709 "Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms"; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms" dated September 2007. The guidance document is intended to provide guidance to manufacturers using spore- forming microorganisms in the production of certain biological products. The guidance document provides recommendations to industry in response to changes made to the requirements for spore-forming microorganisms to allow greater flexibility in manufacturing. The guidance announced in this notice finalizes the draft guidance entitled "Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms" dated February 2005. 2007-09-07 2007 9 https://www.federalregister.gov/documents/2007/09/07/E7-17709/guidance-for-industry-manufacturing-biological-intermediates-and-biological-drug-substances-using https://www.govinfo.gov/content/pkg/FR-2007-09-07/pdf/E7-17709.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms" dated September 2007. The...

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