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Tag Archives: Food and Drug Administration
Rare Diseases Deserve Access to Accelerated Approval – Call Congress TODAY!
Rare Diseases Deserve Access to Accelerated Approval – Call Congress TODAY!
http://www.congressweb.com
The FDA recently issued a draft guidance on the Expedited Approval Programs which they say fulfills the FDASIA mandate on Accelerated Approval for Rare Diseases, however the guidance does not address specific issues related to rare disease drug development as required by FDASIA. This is unacceptable! Continue reading
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Posted in Charcot-Marie-Tooth disease
Tagged Accelerated Approval, Charcot-Marie-Tooth, Clinical trial, CMT, Congress, FDA, FDA Fast Track Development Program, FDASIA, Food & Drug Administration Safety, Food and Drug Administration, nerve disorder, Neuromuscular disease, Peripheral neuropathy, Rare disease
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Budget Control Act of 2011 could have a devastating effect on research
Under the Budget Control Act of 2011, federal programs face an across-the-board funding cut of nearly 8 percent in January 2013, if Congress hasn’t reached agreement on a budget deficit reduction plan. Continue reading
Posted in ALS, Alzheimer's, Charcot-Marie-Tooth disease, Health CMT, human clinical trials, MS, neuromuscular disease, Parkinson's, peripheral neuropathy, Rare disease day, STAR, stem cell research
Tagged Budget Control Act of 2011, CMT, Congress, disease advocacy organizations, FDA, Food and Drug Administration, National Center, National Institutes of Health, National Organization for Rare Disorders, NIH, NORD, Rare disease, Tom Harkin, Translational Sciences
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