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 ...
JD Supra

FDA may permit Rx-to-OTC switch using additional conditions beyond traditional labeling

On June 27, the U.S. Food and Drug Administration (FDA) published the long-awaited proposed rule “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” (ACNU), which would ...
Medical Xpress

Research: FDA drug labels not proof of patent violation

Federal law requires every prescription drug to include a document describing dosing guidelines, contraindications, results from clinical trials and safety considerations. But a spate of recent court ...
Los Angeles Times

What a drug label doesn’t tell you -- but should

This article was originally on a blog post platform and may be missing photos, graphics or links. See About archive blog posts. The Food and Drug Administration requires a lot of detailed information ...