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FDA announces plan to eliminate orphan drug designation backlog
The FDA has released the details of its Orphan Drug Modernization Plan, developed to eliminate the existing orphan drug request backlog and create a system for timely response deadlines for all future requests. This plan will be one of several efforts as part of the agency’s encompassing Medical Innovation Development Plan.“People who suffer with rare diseases are too often faced with no, or limited, treatment options, and what treatment options they have may be quite expensive due in part to significant costs of developing therapies for smaller populations,” Scott Gottlieb, (Read more...)