The federal government re-ignited a controversial proposal to give generic drug makers the power to unilaterally update product labels to reflect new safety information, a proposal that drew criticism ...
Brian Coggio, Karrie Wheatley Ph.D. Courts may infer the requisite specific intent from statements that appear in the generic manufacturer’s label. “When proof of intent depends on the label ...
Supreme Court set to consider cert. petition on generic drug use of “skinny labels” to avoid infringing method of use patents. Court expected to consider cert. petition during court conference on May ...
The U.S. Court of Appeals for the Federal Circuit sided with a jury’s 2017 finding that Teva swayed doctors away from using GlaxoSmithKline’s drug Coreg (carvedilol) for a use of its drug that was ...
The program has demonstrated savings but legal challenges threaten its future. Medicare Part D saved nearly $15 billion over six years with the use of "skinny label" generics, a new report says.
The vast majority of patients who initiated imatinib therapy for gastrointestinal stromal tumors (GISTs) received a generic drug that did not have FDA approval for that indication, a large ...
(CN) - A child who needed a liver transplant after taking generic ibuprofen and going into organ failure can pursue failure-to-warn claims under state law against the drug manufacturer, the 9th ...
After a ‘skinny label’ was used to market a generic version of a pricey brand-name medicine, more consumers gained access to the lower-cost copycat drug and saved on out-of-pockets cost, a new study ...
{mosads}That rule should help drug companies notify consumers about possible risks and dangers in drugs, proponents hope. In a statement after the regulatory agenda was published, Sen. Patrick Leahy ...