Check out this article by Nick Taylor from in-pharmatechnologist.com. This article shares how FDA plans to study foreign regulators’ GMP reports to assist with enforcement efforts. The study will take place from 2013 to 2017 which is the duration of the first generic user fee agreement. The main goal of the study is to boost inspection efficiency and in the long term to reduce current inefficiencies. Regulators across the world are looking to cut efforts that are duplicated and efforts that use limited resources to achieve little or no gain. In order to help the efficiency of this process the FDA also aims to fix current databases and even create more accurate ones. To read the FDA documents which lay out their plan for increased support in generic user fee proposals click here. To find out how the FDA plans to support the extra work that is needed to accomplish their new goals, please click here.
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
Life Science Accelerated
Our experts are dedicated to expediting life science product development regulatory pathways.