FDA continues 'reinvention' process, Genzyme wraps up Seprafilm data, More moves at edge of Alzheimer's

WASHINGTON - The FDA last week formally announced the elimination of lot-by-lot release requirements for well-characterized therapeutic recombinant DNA-derived and monoclonal antibody products, a reform that was announced last month as part of the Clinton administration's "reinvention" of FDA (see BioCentury Extra Nov. 10 and BioCentury Oct. 10).

In the same Federal Register notice on Dec. 8, the agency presented the following interim definition of such well-characterized products, which will be discussed at a public scientific workshop in Washington this week. ...