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FROM MEDSCAPE MEDICAL NEWS: Moderate Wine Drinking Linked to Preserved Cognitive Function

In a Norwegian long-term population-based study, moderate wine drinkers had better cognitive test scores after 7 years' follow-up compared with teetotalers and those who rarely drank alcohol, researchers report in July in Acta Neurologica Scandinavica. "Our observations support results from other studies which indicate that light-to-moderate wine consumption could protect against cognitive decline and possibly also vascular and Alzheimer's dementia," first author Kjell A. Arntzen, MD, from the departments of Community Medicine and Neurology, University of Tromsø, Norway, and colleagues conclude. Reached for independent comment on the study, Mary Ganguli, MD, MPH, professor of psychiatry, neurology, and epidemiology at University of Pittsburgh, Pennsylvania, said: "I don't think...

GUIDANCE FOR INDUSTRY: Label Comprehension Studies for Nonprescription Drug Products

The Food and Drug Administration (FDA) sometimes requires sponsors to conduct label comprehension studies that are designed to evaluate proposed nonprescription drug product labeling. This guidance is intended to provide recommendations to industry on conducting label comprehension studies. A label comprehension study assesses the extent to which consumers understand the information on nonprescription drug product labeling and then apply this information when making drug product use decisions in a hypothetical situation. Data derived from a label comprehension study...

FDA Establishes New Public Docket

The Food and Drug Administration (FDA) is establishing a public docket to obtain input on methods to co-develop two or more distinct investigational drugs intended to be used in combination to treat a disease or condition. FDA is planning to...