US FDA Not Missing Assessment Goals, But Guidance Reminds That It’s Possible
New Q&A guidance also states that its near-term focus for resources will be on coronavirus and some other conditions.
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US FDA issues controversial use emergency authorization for blood plasma therapy while agency officials note workloads nearly double under coronavirus treatment acceleration program. This and more in the Pink Sheet's latest coronavirus update.
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.
The End Of The FDA Approvals Boom? Fewer Applications Are A COVID-19 Consequence
Applications for US FDA approval are lower than in recent history, portending a lean 2021.