Smaller sponsors are likely to feel the biggest impact from the US Food and Drug Administration’s stance that oncology drug confirmatory trials must be ongoing at the time of accelerated approval.
Accelerated Approval: Sponsor Size No Excuse For Confirmatory Trial Delays, FDA Says
There is a greater commitment among larger, well-capitalized oncology companies to complete confirmatory trials, Oncology Center of Excellence Director Richard Pazdur says; smaller company approach of first getting accelerated approval and then using commercial proceeds to capitalize confirmatory trial is ‘unacceptable.’
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The European Medicines Agency is set to issue opinions this week on whether pan-EU marketing approval should be granted to a number of new products.
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