Essentials of Regulatory: Strategies for Speeding the Review of Drug and Medical Device Applications in the US, Canada and the EU
Posted 01 July 2010 | By
Regulatory agencies believe that it is in the best interest of their constituents to review potentially life-saving drugs and devices as early as possible. Alternative approval pathways to speed up development and commercial introduction are available for some drugs and devices. Typically, these candidate drugs and devices must meet certain criteria to qualify for accelerated review. For example, they may need to diagnose or treat serious diseases, address an unmet medical need, provide significant improvement over existing therapies or tests, or address major public health interests or even a national security issue. This article provides an overview on various strategies to expedite drug and/or device approvals in the US, Canada and the EU.