Adaptive Trial Designs Need Elaborate Firewalls To Prevent Data "Leakage," US FDA Says
Sponsors should realize that only a very few people – think 4, not 50 – will be permitted to be unblinded, CDER's Laura Lee Johnson tells the DIA annual meeting.
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Pink Sheet reporters and editor discuss the future of coronavirus products with an emergency use authorization, potential pandemic-inspired regulatory changes at the FDA, and preview the agency’s upcoming advisory committee meeting on coronavirus vaccines.