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Apr 29, 20204 min read
Compiling US Orphan Drug Designation Requests
In the United States, the Orphan Drug Act (ODA) was passed in 1983 to facilitate the development of drugs or biologics that are used for the
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Sep 6, 20194 min read
FDA Ad-Promo Series: Navigating eCTD Submissions for Accelerated Approval Products
Background on Subpart H/E Products For life-threatening diseases where there is no current marketed treatment, the FDA may allow for an...
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