The U.S. House of Representatives recently passed the FDA Reauthorization Act of 2017. This bill seeks to change the requirement for companies to report medical device malfunctions to the FDA. Previously, companies had to...more
Last week, the U.S. House of Representatives (the House) passed by voice vote the FDA Reauthorization Act of 2017 (FDARA or the Act). Introduced on May 16, 2017 by House Energy and Commerce Committee Chairman Greg Walden...more
On May 11 and June 7, the Senate HELP Committee and House Energy and Commerce Committee, respectively, both advanced bipartisan legislation to reauthorize four different user fee agreements that account for over a quarter of...more
Just as the public comment period for the bicameral, bipartisan discussion draft of the “FDA Reauthorization Act of 2017” ended on Friday, what we have been calling the User Fee Games got even more interesting and engaging....more