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 ...

The Skinny Labels, Big Savings Act was introduced on January 9 in an effort to provide “a statutory safe harbor from patent ...

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 ...

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 ...

CINCINNATI (CN) - A woman who developed a neurological disorder while taking a generic acid reflux drug can pursue her failure-to-warn claims in state court, the 6th Circuit ruled. Eleanor Fulgenzi ...

Pushed off by an early March snowstorm, the tussle over whether generics drugmakers should be granted the latitude—or burden, depending on the point of view—to change product labels is being given a ...

(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 ...

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 ...

{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 ...