miércoles, 15 de enero de 2020

FDA is approving more drugs with faster review times

Morning Rounds
Shraddha Chakradhar

FDA is approving more drugs with faster review times

As the FDA has steadily greenlighted more drugs in recent years, a new study that examined approvals going back to 1970 reveals that the agency has also relied on less — and sometimes weaker — evidence. The use of mechanisms for expedited review — including accelerated approval — has also increased over time. The proportion of drugs that were approved with data from at least two major trials decreased from almost 81% between 1995-1997 to around 53% between 2015-2018. In 1983, the FDA spent around three years reviewing drug applications, but that dropped to less than a year in 2017. Still, the time for a drug to go from clinical testing to FDA approval has stayed consistent at around eight years. 

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