Washington, DC - The U.S. Food and Drug Administration is alerting hospitals, laboratories and providers of a Class 1 recall of Beckman Coulter DxH 800, DxH 600 and DxH 900 hematology analyzers—devices that run blood tests to help providers diagnose diseases and conditions such as anemia (low red blood cell or hemoglobin count), infections, blood clotting problems, blood cancers and immune system disorders. This is an update to an urgent medical device correction letter first issued by the company in 2018, after the company received complaints of inaccurate blood platelet counts.

Washington, DC - Today, the U.S. Food and Drug Administration cleared for marketing two tests that can detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause the sexually-transmitted infections, respectively, chlamydia and gonorrhea, through diagnostic testing of extragenital specimens. The Aptima Combo 2 Assay and the Xpert CT/NG are the first devices cleared for extragenital diagnostic testing of these infections via the throat and rectum. These tests were previously only cleared for testing urine, vaginal and endocervical samples.

Washington, DC - A new Federal Trade Commission staff report found that, despite a considerable increase in the total number of final Hatch-Waxman patent settlements in FY 2016, significantly fewer settlements included the types of reverse payments that are likely to be anticompetitive.

Washington, DC - New clinical research supported by the National Institutes of Health shows that increasing the intensity of treatment for alcohol use disorder (AUD) over time improves alcohol-related outcomes among people with HIV. This stepped approach to AUD treatment also improves HIV-related disease measures in this patient population.  A report of the new study, led by researchers at Yale University, is now online in The Lancet HIV.

Washington, DC - New findings from a study by researchers at the National Cancer Institute (NCI), part of the National Institutes of Health, show that U.S. incidence rates for aggressive subtypes of uterine cancer rose rapidly among women ages 30 to 79 from 2000 to 2015. The findings also reveal racial disparities, including higher incidence of these aggressive subtypes and poorer survival—irrespective of subtype and cancer stage—among non-Hispanic black women than among women in other racial/ethnic groups.

Washington, DC - U.S. Secretary of Agriculture Sonny Perdue today announced that the U.S. Department of Agriculture (USDA) will take several actions to assist farmers in response to trade damage from unjustified retaliation and trade disruption. President Trump directed Secretary Perdue to craft a relief strategy to support American agricultural producers while the Administration continues to work on free, fair, and reciprocal trade deals to open more markets in the long run to help American farmers compete globally. Specifically, the President has authorized USDA to provide up to $16 billion in programs, which is in line with the estimated impacts of unjustified retaliatory tariffs on U.S. agricultural goods and other trade disruptions.