RAPS

Generic Drug Labels: FDA Offers Draft Guidance on Updates After Reference Products are Withdrawn

The US Food and Drug Administration (FDA) on Friday released draft guidance describing the process for drug companies when they have to update a generic’s label after the reference product (for which ...
JD Supra

Skinny Facts May Limit Supreme Court’s Decision in ‘Skinny Label’ Generic Drug Approval Case

The Supreme Court on Jan. 16, 2026, agreed to decide a case about how generic companies can communicate to the market about their products, including whether their product promotion may infringe ...
Hosted on MSN

SCOTUS grapples with marketing of Vascepa generic with 'skinny label'

How far can a generic drugmaker with a so-called skinny label go in publicizing a generic version of a brand-name drug? The Supreme Court heard arguments on this question Wednesday, but didn't give a ...
Law

FDA Rule for Generic Drug Labels Would Alter Scope for Tort Liability

A proposed FDA rule, if adopted, would change the current drug-labeling process significantly and impose new requirements and costs on generic drug manufacturers. Courts have relied on the differences ...
RAPS

FDA Now Able to Temporarily Approve Generic Drugs Using Different Label than RLD

The US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD), part of its Center for Drug Evaluation and Research (CDER), is out with the new policy that aims to clarify how its staff ...
Reuters

Generic drugmakers ramp up campaign against FDA label proposal

WASHINGTON (Reuters) - Generic drugmakers are furiously campaigning against a proposed U.S. rule that would require them to change the prescribing information on their products if they receive new ...