New challenges to navigate to reach regulatory approval, report finds

A number of changes in how the US Food and Drug Administration (FDA) perceives rigorous trial design have been noted in a report on the evolving FDA approval processes for biotech companies in Asia Pacific, Europe, and the USA, including typical impediments to success.

The GlobalData report, which was commissioned by Novotech, the Asia Pacific-centered biotech contract research organization (CRO), outlines the global approval landscape, pathways to approval, some frequent missteps to avoid, the importance of formulating a robust clinical development program, and what to expect from a CRO to optimize the process for success.

There are four major changes noted in the way that the FDA operates and in the wider public health landscape which are pointed out by the report.