Pandemic Taking Its Toll On The US FDA’s Non-Pandemic Work, Alkermes CEO Says
Last year was not the greatest performance by the agency outside of COVID-19, Richard Pops tells BIO conference.
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As agency implements testing program for its staff, sponsors are drawing up protocols to ensure inspector safety and forwarding them to FDA, but still can’t trigger an inspection.
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.
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.