Tuesday, July 24, 2012

President Obama signs the FDA Safety and Innovation Act

On July 9th, President Obama signed into law the FDA Safety and Innovation Act, legislation with many provisions to support research and treatments for rare disorders. 
Among the new law’s provisions of interest to the rare disease community: 
Provisions to encourage accelerated patient access to new medical treatments
The development of Humanitarian Use Devices (medical devices for small patient populations)
Accelerated development of “breakthrough therapies” that show early promise 
Enhanced FDA consultation with rare disease experts
A rare pediatric disease priority review voucher incentive program to encourage development of treatments for rare pediatric disorders 
Resolution of conflict of interest issues that have kept some rare disease experts out of the decision making process
Research into how to make drug labels more accessible to the blind and visually impaired 

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