BIOLOGICS "ONE-TIME" FULL CHARACTERIZATION FOR "WELL-CHARACTERIZED" PRODUCTS PROPOSED BY BIO/PhRMA; DEFINITION EXPANDED TO INCLUDE THREE OTHER CLASSES
Executive Summary
Biologic products would be thoroughly characterized at one point during development, the Biotechnology Industry Organization and the Pharmaceutical Research & Manufacturers of America proposed at a Dec. 11-13 FDA/industry "Characterization of Biotechnology Pharmaceutical Products Workshop" held in Washington, D.C.