United States:
FDA Issues Priority Review Voucher For Rare Pediatric Disease Product
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In the April 7, 2015, Federal
Register, FDA announced it has issued a priority
review voucher for Cholbam (cholic acid), pursuant to authority
provided in the Food and Drug Administration Safety and Innovation
Act. Cholbam is a bile acid indicated for the treatment of bile
acid synthesis disorders and other peroxisomal disorders.
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The purpose of this quarterly tracker is to identify key federal and state health AI policy activity. Below reflects federal legislative and regulatory activity to date related to AI...