miércoles, 19 de abril de 2017
FDA gana Al sprint en regristros a EMEA...
A mid ongoing skepticism of the US Food and Drug Administration, a new analysis finds the agency is notably faster at reviewing and approving new medicines than its counterpart in Europe. And the researchers suggest the results, which resemble an earlier comparison, should reassure FDA critics as Congress looks to renew a law that allows the agency to collect industry funds for product reviews.
Of 142 drugs that were approved by both agencies between 2011 and 2015, the median review time at the FDA was 303 days, while the European Medicines Agency took 369 days. For all drugs either one or the other agency approved during that time, the FDA was also quicker — the median review time was 306 days versus 383 days at the EMA, according to the analysis published in The New England Journal of Medicine. (Más)