Content by Scott Gottlieb
Investing in Advanced Domestic Drug ManufacturingEmbracing change may mean a regulatory paradigm shift for the FDA
Tue, 08/07/2018 - 12:03
There’s new technology that can improve drug quality, address shortages of medicines, lower drug costs, and bring pharmaceutical manufacturing back to the United States. At the U.S. Food and Drug Administration (FDA), we’re focused on propelling…
New Steps to Facilitate Medical Device InnovationThe least burdensome approach
Tue, 02/06/2018 - 12:01
In recent days, the U.S. Food and Drug Administration (FDA) has committed to several new policies that will modernize the agency’s approach to regulation in the medical device system. For instance, we announced our intention to propose an…
Some of the FDA’s Major Policy Goals for 2018A year of advancing innovations, empowering consumers, and streamlining regulations
Tue, 01/16/2018 - 12:01
Twice a year the federal government publishes the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda), which provides the American public with insight into regulations under development or review throughout the federal…
FDA Eases Application Process for Compassionate UseFDA recognizes that time is critical for seriously ill patients who do not have alternative therapies
Tue, 10/24/2017 - 12:01
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…
Fostering Medical InnovationA plan for digital health devices
Wed, 07/19/2017 - 12:03
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…