President Trump signs FDARA

On Friday, President Trump signed the FDA Reauthorization Act of 2017 (FDARA) into law, which in effect reauthorized PDUFA and user fees for biosimilars, generic drugs and medical devices.

The House and Senate each passed the legislation on July 12 and Aug. 3, respectively, and committees in both chambers with jurisdiction over FDA agreed on the final language (see BioCentury Extra, July 12 and Aug. 3)...