Content By Scott Gottlieb

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By: Scott Gottlieb

The FDA has a long history of supporting patient access to investigational new treatments. This includes working with drug and device companies through the clinical trial process that may lead to FDA approval of the treatment. We also offer expanded access programs that provide investigational drugs and devices to patients with serious conditions (generally prior to product approval) when there is no therapeutic alternative.

Scott Gottlieb’s picture

By: Scott Gottlieb

It is incumbent upon the U.S. Food and Drug Administration (FDA) to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable the efficient development of these technologies. By taking an efficient, risk-based approach to our regulation, the FDA can promote health through the creation of more new and beneficial medical technologies.