Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability

Streszczenie

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 The guidance announced in this notice finalizes the draft guidance of the same title.