The U.S. Food and Drug Administration is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic.
The nation’s blood supply requires a steady supply of donors who generously donate millions of units of potentially life-saving blood and blood components each year.
Protecting the health and safety of our staff and their families is of paramount concern to the U.S. Food and Drug Administration.
The test will be used on the company's m2000 RealTime system that is currently available in hospitals and molecular laboratories in the U.S.
U.S. Food and Drug Administration took steps to help prevent disruptions in the food supply-chain by issuing a temporary policy for FDA Food Safety Modernization Act (FSMA) supplier verification onsite audit requirements during the coronavirus (COVID-19) public health emergency.
As part of our ongoing and aggressive commitment to address the coronavirus outbreak, the FDA updated a policy originally issued on Feb. 29 on diagnostic testing for coronavirus (COVID-19) in order to achieve more rapid testing capacity in the U.S. We believe the unprecedented policy set forth in today’s updated guidance, which addresses laboratories and commercial manufacturers, will help address these urgent public health concerns by helping to expand the number and variety of diagnostic tests, as well as available testing capabilities in health care settings, and reference and commercial laboratories.
Yesterday, the U.S. Food and Drug Administration took two significant actions in the agency’s ongoing and aggressive commitment to address the coronavirus outbreak (COVID19).
The U.S. Food and Drug Administration today launched an initiative to help consumers use the new Nutrition Facts label that appears on packaged foods to maintain healthy dietary practices.
Today, we are providing an update on the status of U.S. Food and Drug Administration inspections outside of the U.S. in response to the COVID-19 outbreak.
The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters to seven companies for selling fraudulent COVID-19 products.
Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, based in Hyderabad India, received FDA approval for their generic version of Thiotepa 15mg and 100mg vials for injection.
*vorvida® clearance from FDA anticipated Q2 2020. Expects to launch its first digital therapy in the US for heavy alcohol use in H2 2020
Over the past year, the U.S. Food and Drug Administration has embarked on a comprehensive evaluation of cannabidiol (CBD) products, with a focus on educating the public about the risks and unknowns of these products, gathering the science needed to better understand both these safety concerns and potential benefits to inform our regulatory approach, as well as taking steps when necessary to address products that violate the law in ways that raise a variety of public health concerns.
Products become the first and only indicated to reduce blood culture contamination
Purolite Ltd., a leading manufacturer of resin-based separation, purification and extraction technologies, today announces that Praesto® Jetted A50, an agarose-based Protein A chromatography resin, has been incorporated into the commercial manufacturing process of an FDA-approved monoclonal antibody treatment by one of the world's leading contract manufacturing organizations.
Allergan continues five ongoing Phase 3 studies with DURYSTA™ to support further potential FDA label enhancement and rest of the world approvals
FDA, EPA and USDA coordinating on education effort to highlight science behind GMOs
Devices Found to Present Unreasonable and Substantial Risk of Illness or Injury
In a letter to the Food and Drug Administration (FDA), AACC is urging the agency to allow clinical laboratories to develop coronavirus tests without going through FDA review.
