Firms That Get Complete Response Letters Might Get Inspected By US FDA Six Months After Replies
Pandemic Continuing to Make Travel Difficult For Inspectors
While COVID-19 continues to wreak havoc on FDA's ability to perform onsite preapproval inspections, new guidance offers some clarity, but the news isn't great for ANDA holders.
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FDA reviewers stuck to established assessment practices during the coronavirus crisis and produced one of the agency’s largest yearly novel approval counts ever.
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.