MANUFACTURING CHANGES LANGUAGE AGREED TO BY FDA AND INDUSTRY TO RESOLVE ONE AREA OF CONTENTION IN REFORM BILL: SUMMARY DATA, INFO DISSEMINATION REMAIN
Executive Summary
"Major manufacturing changes" requiring FDA preapproval via a supplemental application would be defined by three criteria in a recent agreement between industry representatives and FDA on proposed language for Sen. Kassebaum's (R-Kan.) FDA reform bill (S 1477).