PDUFA VII Talks To Begin With COVID-19, Other Familiar Issues To Consider
US FDA staffing problems and patient engagement enhancements will be listed as priorities during reauthorization kick-off meeting.
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Will the US FDA agree to more structured communications amid its struggles with the existing meeting workload?
Timelines in the CID program are tight, and sponsors should have a ‘fully baked’ trial design before heading into their first meeting with the agency, industry reps say; agency needs more simulation data from participating sponsors earlier and is working to ensure continuity for firms after the second of two meetings allowed under the program.
As agency prepares to hear from stakeholders on its strategy, real-world data precedents already are being set thanks to COVID-19, Aetion tells the Pink Sheet.