Topic: Generics

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 »

Supreme Court Rules Generic Drug Makers can Challenge Brand-Name Patents

On April 17, 2012, the Supreme Court ruled in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S that generic drug makers can sue brand-name drug makers when the latter claim exaggerated descriptions of indications covered by their patented drugs. The Food and Drug Administration has historically allowed brand-name drug makers to write their own descriptions… Read more »