What Pandemic Effect? US FDA’s 2021 Approval Class Is Off To Strong Start With 60+ Novel Candidates
Dermatology, chronic kidney disease and liver disease therapies stand out in a crowd of user fee goals that is actually bigger than at the same point in 2020.
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Wall Street is worried that a cluster of recent negative regulatory events means tougher reviews going forward. That concern is probably overdone, but a year into the COVID pandemic is a good time to take stock of how FDA is doing.
Last year was not the greatest performance by the agency outside of COVID-19, Richard Pops tells BIO conference.
Acting CDER Director Cavazzoni says it is ‘a very active time’ as many clinical trials for COVID-19-related products are expected to read out soon.