US FDA Resumes China, India Inspections In Bid To Keep Drug Approvals On Schedule
Agency’s struggle to meet user fee commitments despite travel restrictions expected to worsen as pandemic continues into 2021.
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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.
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.