Topic: FDASIA

New FDA User Fee Law Includes Biosimilar & Generic Drug Approval Pathways

On July 9, 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law. The new legislation extends through 2017 the FDA’s program of charging user fees on drug applications – used to pay the agency’s employee salaries – in exchange for a quicker and more transparent product review process.… Read more »