Posted by Michael Wonder on 02 Feb 2022
Global consequences of the US FDA's accelerated approval of cancer drugs
1 February 2022 - The accelerated approval system is a fast track drug approval pathway created by the US FDA in 1992 in response to the HIV-AIDS crisis to allow expedited access to life-saving drugs and fulfil an unmet medical need. Nowadays, this pathway is most commonly used for cancer drug approval.
In theory, the accelerated approval pathway strikes a balance between early access to therapies and the need for robust evidence generation.
