Rare Disease Drugs Need Faster Development Track, Sen. Brownback Tells FDA
Sen. Sam Brownback, R-Kansas, told FDA it should establish a second track for the development and approval of drugs for rare and neglected diseases
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September public hearing will continue FDA's look into rare and neglected disease drug development.
FDA is not setting a precedent by considering Orphan Europe's orphan drug Carbaglu for approval without a clinical trial, FDA's Office of Drug Evaluation III Director Julie Beitz indicated after the Endocrine and Metabolic Drugs Advisory Committee's Jan. 13 vote for approval
A Rare Opportunity? FDA Orphan Products Head Makes The Case For More Big Pharma Investment In Rare Diseases
"Over the last 26 years, large pharmaceutical companies have missed an incredible opportunity," says Tim Coté, head of the Food & Drug Administration's Office of Orphan Product Development