Washington, DC - “The De Novo pathway for novel medical devices allows the FDA to conduct a rigorous review of new technologies so that patients have timely access to safe and effective medical devices to improve their health," said FDA Commissioner Scott Gottlieb, M.D. “At the same time, the FDA is modernizing its 510(k) pathway, which is used for clearance of low- to moderate-risk devices that are substantially equivalent to a device already on the market. The De Novo pathway provides a vehicle for establishing new predicates that can reflect modern standards for performance and safety and can serve as the basis for future clearances.

Dallas, Texas - A healthy lifestyle during the transition to menopause may offset the acceleration of atherosclerosis, the slow narrowing of the arteries that increases with age, according to new research in the Journal of the American Heart Association, the Open Access Journal of the American Heart Association/American Stroke Association.

Washington, DC - A new commentary from National Institutes of Health scientists asserts that engaging men in HIV prevention and care is essential to the goal of ending the HIV pandemic. The article by Adeola Adeyeye, M.D., M.P.A., and David Burns, M.D., M.P.H., of the National Institute of Allergy and Infectious Diseases (NIAID) and Michael Stirratt, Ph.D., of the National Institute of Mental Health (NIMH) also discusses potential solutions.

Washington, DC - “CDC continues to investigate a multistate outbreak of E. coli O157 infections linked to romaine lettuce. We understand this outbreak is of concern to many Americans – especially with so many gathering for meals this Thanksgiving week. CDC’s disease detectives are working with federal regulatory partners to investigate and determine the source of contamination as quickly as possible. We will continue to provide more information as it becomes available. The good news is we were able to detect and identify the outbreak quickly through our disease surveillance system, which can prevent further illness.

Washington, DC - Presidential Proclamation on World AIDS Day, 2018:

Washington, DC - CDC Director Robert R. Redfield, M.D., announced Monday the establishment of an Acute Flaccid Myelitis (AFM) Task Force (Task Force) to aid in the ongoing investigation to define the cause of, and improve treatment and outcomes for, patients with AFM.