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FDA's accelerated drug approval process plagued by missing efficacy data and questionable evidence

FDA's accelerated drug approval process plagued by missing efficacy data and questionable evidence
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Elisabeth Mahase , Celecoxib Celebrex , Rachel Sachs , Huseyin Naci , Emily Henderson , Us Government Accountability Office , Washington University , Institute For Clinical , London School Of Economics , Drug Administration , London School , Accountability Office , Economic Review , ரேச்சல் சாக்ஸ் , எமிலி ஹென்டர்சன் , எங்களுக்கு அரசு பொறுப்பு அலுவலகம் , வாஷிங்டன் பல்கலைக்கழகம் , நிறுவனம் க்கு மருத்துவ , லண்டன் பள்ளி ஆஃப் பொருளாதாரம் , லண்டன் பள்ளி , பொறுப்பு அலுவலகம் , பொருளாதார விமர்சனம் ,

Investigation finds nearly half of drugs granted FDA 'fast track' approval lack proven clinical benefit

Process plagued by missing efficacy data and questionable evidence
Some experts argue that FDA’s standards for evidence are too low
Since the US Food and Drug Administration (FDA) established its accelerated approval pathway for drugs in 1992, nearly half (112) of the 253 drugs authorised have not been confirmed as clinically effective, an investigation by The BMJ has found.
Elisabeth Mahase, clinical reporter at The BMJ, carried out an in depth analysis of FDA data up to 31 December 2020 and found that of these 112 drugs approved in the last 28 years a fifth (24) have been on the market for more than five years and some have been on the market for more than two decades – often with a hefty price tag. ....

Elisabeth Mahase , Celecoxib Celebrex , Rachel Sachs , Huseyin Naci , Us Government Accountability Office , Washington University , Institute For Clinical , London School Of Economics , Drug Administration , London School , Accountability Office , Economic Review , ரேச்சல் சாக்ஸ் , எங்களுக்கு அரசு பொறுப்பு அலுவலகம் , வாஷிங்டன் பல்கலைக்கழகம் , நிறுவனம் க்கு மருத்துவ , லண்டன் பள்ளி ஆஃப் பொருளாதாரம் , லண்டன் பள்ளி , பொறுப்பு அலுவலகம் , பொருளாதார விமர்சனம் ,