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FDA OFFICES OF SUPPLEMENTAL APPROVALS WOULD BE ESTABLISHED BY AMENDED KASSEBAUM BILL; "MEDGUIDE" WOULD BE BLOCKED BY COATS AMENDMENT

Executive Summary

FDA would be required to establish offices of supplemental approval in each of its centers under the version of Sen. Kassebaum's (R-Kan.) FDA reform bill that emerged from committee mark-up March 28. The provision is part of an amendment promoting the submission and approval of NDA supplements that was introduced by Sen. Kennedy (D-Mass.) and approved on a voice vote.
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