Although House Republicans made progress on bridging ideological differences over how to replace the Affordable Care Act (ACA), GOP leaders say not to
Congress passed the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) to give the U.S. Food and Drug Administration (“FDA”) new authority
Under FDA regulations, generic drugs must be chemically equivalent, have the same active ingredients, and be bioequivalent to their branded
On June 23, 2011, the U.S. Supreme Court issued a decision in Pliva, Inc. v. Mensing,1 holding that state-law claims against generic drug manufacturers are federally preempted pursuant to the Supremacy Clause of the U.S. Constitution.
In this article, we examine the issues surrounding the regulation of biosimilar drugs in Australia, including pricing issues under the Pharmaceutical Benefits Scheme.
The U.S. Supreme Court is considering whether a generic drug maker can be held liable under state law for failing to include on its drug label safety information not yet used by name brand manufacturers or required by the Food and Drug Administration (FDA).
The U.S. Supreme Court is considering whether a generic drug maker can be held liable under state law for failing to include on its drug label safety information not yet used by name brand manufacturers or required by the Food and Drug Administration (FDA). PLIVA, Inc. v. Mensing, No. 09-993 (U.S., oral argument, March 30, 2011).
The concept of "interchangeability" of medicines was first introduced in 1997 when the government introduced therapeutic groups, which grouped together drugs that were considered to be therapeutically interchangeable on the basis of having similar safety and efficacy profiles, and health outcomes.
Does the inventor or "innovator" of a brand-name drug have a duty of care to the consumers of that drug's generic equivalent manufactured by a competitor?
On August 9, 2010, the Food and Drug Administration ("FDA") published a notice announcing a public meeting to be held September 17, 2010, "to gather stakeholder input on the development of a generic drug user fee program."