federal_register: E8-28693

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E8-28693 Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics," dated November 2008. The guidance document provides information concerning cooperative manufacturing arrangements applicable to biological products subject to licensure under the U.S. Public Health Service Act (PHS Act). The guidance describes the licensing strategies for meeting the increased need for flexible manufacturing arrangements. The guidance announced in this notice finalizes the draft guidance of the same title. 2008-12-04 2008 12 https://www.federalregister.gov/documents/2008/12/04/E8-28693/guidance-for-industry-cooperative-manufacturing-arrangements-for-licensed-biologics-availability https://www.govinfo.gov/content/pkg/FR-2008-12-04/pdf/E8-28693.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: Cooperative Manufacturing Arrangements for Licensed Biologics," dated November 2008. The guidance document provides information...

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