13 March 2017 - The US FDA has primary responsibility for oversight of every drug, biologic, and medical device sold in the United States. Yet the FDA is far more than a regulator.
It is also an agency dedicated to public health, with the expertise of thousands of scientists and access to enormous amounts of information from clinical trials and other studies. Greater transparency can allow FDA not only to better meet its many obligations but also to advance the scientific enterprise needed to develop safe and effective medical products.
In 2009, FDA launched an initiative to make more regulatory decisions and analyses available to the public. After receiving extensive comment, the agency developed a series of draft proposals. Although FDA moved some of these proposals forward, others were never implemented.