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 (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.
Only 42% of people living with Type 1 diabetes count carbohydrates to determine their mealtime insulin dose according to the 2019 Seagrove Partners' Patients Perspectives Report.
To ensure the safe and effective cleaning of CPAP devices and accessories, the FDA is recommending that consumers and health care providers follow the cleaning instructions provided by the CPAP’s manufacturer, which normally include regular cleaning with soap and water.
Innocoll anticipates a 6-month review by the FDA.
LPMs are used during laparoscopic (minimally invasive) surgeries to cut tissue into smaller pieces so the tissue can be removed through a small incision site.
The U.S. Food and Drug Administration today authorized marketing of the first test to detect a genetic condition known as Fragile X Syndrome (FXS), the most common known cause of inherited developmental delay and intellectual disability.
Pharmacogenetic testing is a type of genetic test that in some instances can predict how a person will respond to specific medications.
