Friday, 25 May 2012

PPMD endorses Senate version of Prescription Drug User Fee Act (PDUFA) after patient voice strengthened - PPMD Community

PPMD endorses Senate version of Prescription Drug User Fee Act (PDUFA) after patient voice strengthened - PPMD Community: As the U.S. Senate continues debate on legislation that seeks to accelerate delivery of safe and effective therapies to patients and to increase the patient voice as part of the therapy review process, PPMD�is pleased to offer our enthusiastic endorsement of the legislation.

Over the past several months, PPMD�has fought to include several key provisions included in the Senate version of the Food and Drug Administration Safety and Innovation Act, commonly referred to as the Prescription Drug User Fee Act or PDUFA.�A number of similar provisions are also included in a House bill expected to be voted on by that chamber next week.

The provisions included in the Senate user fee bill will help expand the patient voice when key decisions are being made, an issue of grave importance to our community and to the larger rare disease community.�The provisions will also provide the FDA with additional tools to more quickly review potential therapies for life-threatening conditions, including Duchenne.

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