US FDA May Start To Miss User Fee Deadlines
As the COVID-19 response begins to strain agency’s resources, Commissioner Hahn acknowledges that ‘it is possible that we will not be able to sustain our current level of performance indefinitely’ in other review areas.
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Applications for US FDA approval are lower than in recent history, portending a lean 2021.
New Q&A guidance also states that its near-term focus for resources will be on coronavirus and some other conditions.
Coronavirus Notebook: US FDA Cuts Hotline Hours, Regulatory Relief May Be Permanent, Trump's Hydroxychloroquine Prescription
Dispatches from a world turned upside down include approval of more hydroxychloroquine ANDAs, a window into what post-pandemic regs at the US FDA might look like, and some bad news for night shift works who need coronavirus advice from the agency.