CBER’s ‘Courageous’ Coronavirus Guidance Strategy May Catch-On
Director Peter Marks says faster guidance development practices produced well-written documents and may be adopted once the pandemic ends.
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The Center for Drug Evaluation and Research’s policy guru must think about the future, along with the present, in her position as director of the Office of Regulatory Policy.
Human resource managers also worried that since universal teleworking was valued by employees, a return to pre-pandemic conditions could cause a mass exodus.
Standard NMEs and BLAs decrease along with their review times, as more sponsors use priority pathway.