Day: September 14, 2017

It has been argued that because expedited approval pathways allow drugs to be approved with incomplete analysis of safety and efficacy, it potentially leads to new drugs with limited benefit and/or with potential safety concerns. But this is a simplistic one sided argument that does not address the context in which such drugs are approved. … Read more

Why are drugs expensive; is it because the cost of developing new drugs is very high, or that there are onerous regulatory processes for market approval, or may be it takes too long to develop a new drug? And if all these were addressed would it lead to cheaper drugs? This week the FDA Commissioner … Read more