On the recordSeptember 24, 1997
I agree completely with what you just stated. The provisions that have been negotiated between FDA and industry and set forth in the sideletter from the Secretary are a key part of PDUFA. These provisions cover electronic submissions, meeting management goals, clinical holds, major dispute resolution, special protocol question assessment and agreement, and additional procedures, such as action letters. Not only should these performance goals be considered fully binding on the agency, they should be considered as minimum, not maximum commitments. If the agency can do better, it should. I know that FDA will do its best to exceed the performance goals and other matters spelled out in the letter, just as it has exceeded its commitments in the 1992 PDUFA letter. Effective and aggressive oversight of the fda
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