FDA shows unease about marketing approval applications based on single-country trials
Several reasons specified in the ODAC rejection are specific to the sintilimab BLA.
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Milena Izmirlieva
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Is price control by stealth the future for the United States?
There may be ways to introduce price control under federal drug programmes by stealth in the absence of state…
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Seven years on ICER’s review process remains unpredictable
The US Institute for Clinical and Economic Review (ICER) began publishing health technology assessments (HTAs) for innovative medicines in…
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