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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 of Generic Drugs Director Sally Choe said FDA staff are adapting well and that

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