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Pink Sheet Podcast: Dsuvia Warning Letter, Refuse-To-File Impact, CDER’s COVID Workload

Pink Sheet Podcast: Dsuvia Warning Letter, Refuse-To-File Impact, CDER’s COVID Workload

Source : 'The Pink Sheet'

Pink Sheet senior writers Derrick Gingery and Sarah Karlin-Smith and Executive Editor Nielsen Hobbs discuss the political and practical implications of the US Food and Drug Administration’s warning letter on promotion of AcelRx Pharmaceuticals, Inc.’s opioid Dsuvia (sufentanil sublingual), an expected bolus of coronavirus-related work for the Center for Drug Evaluation and Research, and an FDA study of the impact of refuse-to-file actions. 

Dsuvia Gets Warning Letter As US FDA’s Opioid Decisions Complicate Commissioner Race

US FDA Could Be Facing Bolus Of Pandemic-Related Applications

COVID Therapeutics Progress (Or Lack Thereof) May Be Political Vulnerability For US FDA

FDA Refuse-To-File Decisions Are Rare, But CMC And Ignoring Agency Advice Are Often Triggers

 

By Derrick Gingery, Sarah Karlin-Smith, M. Nielsen Hobbs