federal_register: 05-3593

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
05-3593 Draft Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms" dated February 2005. The draft document is intended to provide guidance to manufacturers using spore- forming microorganisms in the production of certain biological products. The draft guidance document provides recommendations to industry in response to changes made to the requirements for spore- forming microorganisms to allow greater flexibility in manufacturing. 2005-02-24 2005 2 https://www.federalregister.gov/documents/2005/02/24/05-3593/draft-guidance-for-industry-manufacturing-biological-drug-substances-intermediates-or-products-using https://www.govinfo.gov/content/pkg/FR-2005-02-24/pdf/05-3593.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 document entitled "Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms" dated February 2005. The...

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