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Regulatory Focus™ > News Articles > Bill Would Encourage FDA to Seek Expert Advice About Rare Diseases

Bill Would Encourage FDA to Seek Expert Advice About Rare Diseases

Posted 08 March 2012 | By Alexander Gaffney, RAC 

Proposed legislation introduced in Congress on 7 March would encourage the US Food and Drug Administration (FDA) to seek and receive advice from experts in the field of rare diseases.

The Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012 (EXPERRT Act) would allow a consultation programs to be established for the purpose of allowing an exchange of expert information. The goal of the program is to allow FDA staff to better inform and strengthen the agency's ability to review therapies for rare diseases.

Experts may include:

  • representatives of patient, consumer, research and health organizations
  • experts on rare diseases
  • experts in innovative clinical trials designs for small target populations

The bill stipulates that the experts will likely be consulted to offer advice about rare diseases, the severity of rare diseases, unmet medical needs, clinical trials, and benefit:risk assessments.


Read more:

House - H.R.4156 -- EXPERRT Act of 2012 (Introduced in House - IH)


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