Following is a copy of an internal FDA draft document outlining the agency's approach for implementing biotechnology-related reforms. The incomplete working document, which was leaked to the press last week, includes addresses an interim definition of well-characterized biologics involving recombinant DNA derived and monoclonal antibody products, their documentation and manufacture. This text also is available this week at :

Interim Definition of a Well Characterized Therapeutic Recombinant DNA Derived and Monoclonal Antibody Biotechnology Product