According to The New York Times, a majority of recent drug developments have involved therapies eligible for one or more of FDA's special approval processes, such as Priority Review and Orphan Drug designation. Usually reserved for urgent, life-saving products, these expedited pathways often demand less evidence of efficacy than the typical approval process, and as a result, many companies have been refocusing their research on applicable therapies. The 21st Century Cures legislation aims to add another special approval process for so-called "dormant" therapies.
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