US FDA flags seizure risk with certain Parkinson's drugs, seeks label warnings

March 20 (Reuters) - The U.S. Food and Drug Administration said on Friday it has notified manufacturers of certain Parkinson's disease treatments to update their prescribing information with a new ...
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 ...
STAT

FDA to stress opioids’ risk of overdose, death in new medication safety labels

Lev Facher covers the U.S. addiction and overdose crisis. The Food and Drug Administration will soon require prescription opioid manufacturers to include stronger language on the medications’ labels ...
BioSpaceOpinion

What the Leucovorin Approval Signals—or Doesn’t—About the FDA’s Rare Disease Stance

Although FDA Commissioner Marty Makary promised “an exciting treatment” for autism, what the agency delivered was a label ...
JD Supra

FDA Updates Food Labeling Compliance Program: What It Means for Food Manufacturers

In June 2025, the US Food and Drug Administration (FDA) announced a major update to its General Food Labeling Requirements Compliance Program—the first overhaul of this program since 2010. This ...
Fierce Healthcare

FDA requires label changes to all opioid pain meds to clarify risks

The FDA is requiring safety labeling changes to all opioid painkillers, to better highlight the risks posed by using the drugs long-term. The changes come after a public advisory committee meeting in ...
JD Supra

Will the Supreme Court Give Drug Manufacturers the Skinny on Induced Infringement?

The Supreme Court may soon address a recent, pivotal case involving the use of “skinny labels” to avoid inducing infringement in pharmaceutical patent infringement cases. The outcome could clarify ...