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 ...

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 ...

In a recent post, I noted the Catch-22 that the Supreme Court insists Congress created with its fast-track approvals for generic drugs. Those who are injured by a brand-name drug can win compensation ...

Federal law requires generic drugs to maintain the same labeling as the brand-name products they reproduce, including warnings of potential side effects. In a 5-4 decision, the court said patients ...

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 Food and Drug Administration (FDA) plans to issue a new rule that will allow generic drugmakers to make changes to their drugs' labeling. Federal law dictates that generic drug labels must be ...

In July 2016, the U.S. Food and Drug Administration (FDA) published draft guidance outlining when drug companies should update a generic drug’s label after the brand name drug on which the generic is ...