Posted by Michael Wonder on 15 Jul 2019
The FDA disagrees with its own expert panels how often?
15 July 2019 - As the FDA grapples with rising pressure to approve new medicines more quickly, a new analysis finds the agency disagreed with its expert advisory panels about one-fifth of the time.
The disagreements were more likely to occur over safety issues than over approving new products or additional uses for existing products.
Of those disagreements, 75% resulted in the FDA making more restrictive decisions after an advisory panel made a favourable recommendation, while 25% resulted in the agency making less restrictive decisions after unfavourable panel recommendations, according to the analysis, which was published in The Milbank Quarterly and reviewed 376 panel meetings that took place between 2008 and 2015.
