Federal law requires every prescription drug to include a document describing dosing guidelines, contraindications, results ...

A new study finds that off-label drug use is associated with higher rates of adverse drug events in adults. Off-label use of prescription drugs is known to be associated with adverse drug events (ADEs ...

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 ...

The vast majority of patients who initiated imatinib therapy for gastrointestinal stromal tumors (GISTs) received a generic drug that did not have FDA approval for that indication, a large ...

The Food and Drug Administration, under heavy criticism over its decision last month to approve Biogen's Alzheimer's drug Aduhelm, has revised the medicine's prescribing information in an effort to ...

Developing standards for the conversion of paper labeling to an electronic format is a high priority for FDA. The content and format revisions to the prescribing ...

The U.S. Food and Drug Administration has approved drug labeling changes to six menopausal hormone therapy products, also known as hormone replacement therapy (HRT), to clarify risk considerations for ...