Posted by Michael Wonder on 30 Mar 2017
FDA officials: priority review drugs have higher likelihood of getting boxed warning after approval
29 March 2017 - A team of officials from the US FDA say that drugs approved following a priority review are three-and-a-half times more likely to receive a boxed warning after entering the market.
Unlike standard reviews, which can take up to ten months, drugs that treat serious conditions or offer a significant improvement over existing treatments can qualify for a shorter, six-month review.
However, the authors note that because drugs given priority review are intended to treat more serious conditions, "a greater degree of inherent risk is medically acceptable."
