A separate section on patient-counseling information has been added in response to the requirement that all FDA-approved patient information be reprinted in or accompany drug product labeling.

Purpose: The revised prescription drug labeling developed by the Food and Drug Administration (FDA) is described. Summary: A new FDA final rule, "Requirements on Content and Format of Labeling for ...

An anxiety drug is being voluntarily recalled over a mislabeling error that could be “possibly life-threatening," according ...

The U.S. Food and Drug Administration and the U.S. Department of Agriculture  have announced a joint request for Information (RFI) about food date ...

The FDA and USDA seek industry and consumer input on food date labeling terms like Sell By, contributing to 20% of food waste ...

Tablets of the drug clonazepam, the generic name for Klonopin, which is used to treat epilepsy, panic disorder and muscle ...

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 ...

IARN – The Food and Drug Administration performs the critical task of providing consumers with clear nutritional information ...