Washington, DC - Today, the U.S. Food and Drug Administration took an important step to better protect consumers from the dangers of highly concentrated and pure caffeine products. These products present a significant public health threat because of the high risk that they will be erroneously used at excessive, potentially dangerous doses. Highly concentrated and pure caffeine, often sold in bulk packages, have been linked to at least two deaths in otherwise healthy individuals.

Washington, DC - The research community now has a new framework toward developing a biologically-based definition of Alzheimer’s disease. This proposed “biological construct” is based on measurable changes in the brain and is expected to facilitate better understanding of the disease process and the sequence of events that lead to cognitive impairment and dementia. With this construct, researchers can study Alzheimer’s, from its earliest biological underpinnings to outward signs of memory loss and other clinical symptoms, which could result in a more precise and faster approach to testing drug and other interventions.

Washington, DC - The U.S. Food and Drug Administration today finalized two guidances to drive the efficient development of a novel technology that scans a person’s DNA to diagnose genetic diseases, which are usually hereditary, and guide medical treatments. The guidances provide recommendations for designing, developing, and validating tests that use the technology, called next generation sequencing (NGS), and will play an important role in the continued advancement of individualized, genetic-based medicine.

Los Angeles, California - Researchers have developed a new approach to repair cells deep inside the ear – a potential remedy that could restore hearing for millions of elderly people and others who suffer hearing loss.

Washington, DC - Each day, an average of 116 Americans die from an opioids overdose. In addition to “hard drugs” such as heroin and illicitly manufactured fentanyl, opioids include a range of prescription medications. It’s estimated that about a quarter of patients who are prescribed opioids misuse them in some way.

Los Angeles, California - High-deductible health plans are touted for their money-saving potential, but a new USC study finds that they can greatly increase the risk of high out-of-pocket healthcare costs for Americans who are low-income or chronically ill - and may topple them into financial disaster.