FDA Floats Plan To Streamline New Drug Trials

Law360, New York (January 6, 2014, 8:01 PM EST) -- The U.S. Food and Drug Administration on Monday finalized a process for creation of standardized metrics that can be widely used during clinical trials to gauge the safety and effectiveness of new medicines, building on similar plans unveiled recently for medical devices.

In the finalized guidance, the FDA outlined how corporations and organizations can propose and win agency backing for so-called drug development tools that can be used in different studies to evaluate a drug.

Tools can take many forms. There are so-called biomarkers that may...
To view the full article, register now.