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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Now that video site tours can sidestep pandemic travel restrictions, an expert who consults for industry on US FDA inspections suggests Congress may want to revise the FD&C Act to sidestep the “site entry” inspections limitation.
Product sampling and remote records requests accounted for most import alerts and drug GMP warning letters over the past year – and may play key role post-pandemic.
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.