1. Pink Sheet

US FDA Not Changing Assessment Goals Because of Coronavirus-Mandated Telework

 
• By Derrick Gingery

Assessment work also isn’t slowing down, the new and generic drug office directors said in an interview, but approval data offers a note of concern.

FDA entrance sign 2016
So far, FDA staff have smoothly transitioned to mass-telework, the Office of New Drugs and Office of Generic Drugs directors said in an interview. • Source: File photo

New and generic drug assessment goals are not expected to be adjusted because of coronavirus-mandated telework, but senior US Food and Drug Administration officials indicated other aspects of the clearance process could affect output.

During a 27 March interview with the Pink Sheet via teleconference, Office of New Drugs Director Peter Stein and Office...

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