FDA shows unease about marketing approval applications based on single-country trials
In 2019, the director of the US FDA’s Oncology Center of Excellence, Richard Pazdur, suggested that the approval pathway for…
All articles by Milena Izmirlieva
Milena Izmirlieva
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Is price control by stealth the future for the United States?
Credit: JLMcAnally As is customary, as January begins, so do price increases in the United States. Several reports tracking January…
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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 2014…