Proposed Modernization of FDA’s Drug Review Office

FDA has proposed an important series of new steps to modernize the organization and functions of CDER’s Office of New Drugs. These changes are intended to free up resources so that our scientists and physicians have more time to focus on drug development, particularly for unmet medical needs, and on the multiple collaborations needed to make sure candidate drugs are developed and assessed properly, with appropriate input from external scientists, expert physicians and patient communities. The proposals include regulatory and review process changes, as well as organizational restructuring. We also intend to strengthen the support structures, including personnel and Information Technology (IT), that underpin the regulatory process.

As always, our goals are to expand access to safe and effective new drug therapies, conduct efficient and comprehensive safety surveillance, and ensure that accurate information about those drugs is available.

Read more in Dr. Janet Woodcock’s FDA Voice Blog and in the Statement from FDA Commissioner Dr. Scott Gottlieb.