JD Supra

FDA and Prescription Drug Use Related Software – FDA’s Draft PDURS Guidance Answers Years-Old Questions and Introduces New Ones

FDA’s recent draft guidance, Regulatory Considerations for Prescription Drug Use Related Software, proposes a regulatory framework for software disseminated by a drug sponsor that supplements or ...
JD Supra

FDA proposes mandatory patient labeling for Rx drugs - Proposed Patient Medication Information (PMI) is the latest in many efforts by FDA to mandate patient-directed labeling

Last week, the U.S. Food and Drug Administration (FDA) published the proposed rule “Medication Guides: Patient Medication Information,” which would significantly change the agency’s prescription drug ...
Cure Today

The FDA Approves Labeling Update for Sandoz in the Treatment of B-Cell CLL

Project Renewal updates older oncology drug labels to ensure clinical relevance and scientific accuracy, involving external experts and early-career scientists. Fludarabine phosphate's updated label ...
Business Insider

FDA Approves Labeling Changes to Menopausal Hormone Therapy Products

White Oak, Md., Feb. 12, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration has approved drug labeling changes to six menopausal hormone therapy products, also known as hormone replacement ...
Augusta Free Press

Fill the safety gap with generic drug prescriptions: Legislation would direct FDA with labeling

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 ...
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 ...
The Times Leader

Fda May Require Cancer-risk Labeling On J&j Drug

WASHINGTON — An experimental drug from a unit of Johnson & Johnson appears effective at treating a severe skin disease, though government regulators said Friday it also could slightly increase cancer ...