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 ...
On October 2, 2020, the Federal Circuit issued a precedential opinion vacating a district court’s judgment as a matter of law and reinstating a jury verdict finding of induced infringement of a ...
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 ...
A new court ruling has the future use of skinny labels in question, but skinny-label generics have saved Medicare a lot of money over 5 years. Skinny labels, which carve out patent-protected ...
Current Federal Drug Administration regulations require a generic drug’s labeling to be the same as its brand-name counterpart. Brand-name drug manufacturers are able to update product labels with new ...
Subcommittee Hearing Monday to Examine FDA's Proposed Changes to Generic Drug Labeling, Which Public Citizen Requested FDA rules prohibit generic manufacturers from updating product labeling even if ...
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 ...
Positron Emission Tomography–Driven Strategy in Advanced Hodgkin Lymphoma: Prolonged Follow-Up of the AHL2011 Phase III Lymphoma Study Association Study Generic competition can be delayed if ...
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