CBER’s ‘Courageous’ Coronavirus Guidance Strategy May Catch-On
Executive Summary
Director Peter Marks says faster guidance development practices produced well-written documents and may be adopted once the pandemic ends.
You may also be interested in...
Califf: More Expedited Approvals Mean US Clearance Only The Beginning Of Learning About Medical Products
The US FDA commissioner said increased use of expedited approval pathways will help spur clinical research system reform.
Elizabeth Jungman: Interpreter Of The FDA’s Policy Crystal Ball
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.
US FDA CDER, CBER Staff Say Pandemic Had Negative Effect On Hiring, Retention
Human resource managers also worried that since universal teleworking was valued by employees, a return to pre-pandemic conditions could cause a mass exodus.