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.
No hay comentarios:
Publicar un comentario