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. By Milena Izmirlieva
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… By Milena Izmirlieva
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… By Milena Izmirlieva