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Table: PDUFA V Commitments
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Monday, July 2, 2012
In addition to reauthorizing the Prescription Drug
User Fee Act, which will generate more than $4 billion in user fees for
FY13-FY17, the Food and Drug Administration Safety and Innovation Act (S.3187)
contains several measures intended to reform FDA. Source: S.3187; FDA
performance goals and procedures
FDA to use Fast Track designation and accelerated approval for "a broad
range of serious or life threatening diseases or conditions"
caps on conflict-of-interest waivers for advisory committee members
anti-infective drugs against pathogens with "potential to pose a serious
threat to public health" receive Priority Review and five years
of exclusivity in addition to any Orphan, NCE or pediatric exclusivity
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