Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics

This information collection supports Food and Drug Administration (FDA) guidance entitled “Guidance for Industry; Cooperative Manufacturing Arrangements for Licensed Biologics.” The guidance document provides information concerning the various cooperative manufacturing arrangements used in the production of biological products subject to licensure under section 351 of the PHS Act (42 U.S.C. 262). It describes FDA's current thinking on licensing strategies for meeting the increased need for planning flexible manufacturing arrangements.

The latest form for Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics expires 2021-04-30 and can be found here.