January 14, 2020 08:23 AM EST

‘Clinical superiority’: diazepam nasal spray illustrates FDA parameters for orphan drug exclusivity

Thanks to the last user fee agreement, known as the FDA Reauthorization Act of 2017, the agency can now explain why a newly approved orphan …

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‘Clin­i­cal su­pe­ri­or­i­ty’: di­azepam nasal spray il­lus­trates FDA pa­ra­me­ters for or­phan drug ex­clu­siv­i­ty