Can We Talk? US FDA Remote Records Review Missteps Worry Industry
Alkermes CRL is just the latest fallout from black-hole process.
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Richard Pops has publicly complained about the agency’s review performance during COVID, and Alkermes’ application for a mental health product appears to have been held up because of inspection issues.
Last year was not the greatest performance by the agency outside of COVID-19, Richard Pops tells BIO conference.
Gilead and Roche ended the year involved in three novel agents apiece, thanks to a combination of internal research and external licensing.