The first warning letters of the year issued by the U.S. Food and Drug Administration were delivered to a seafood processing facility in Hawaii and a dairy operator in Pennsylvania. A warning letter is FDA’s principal means of ...
Tags: FDA, HACCP, violation, Nobuo T.Hawaii
Affymetrix, Inc. (NASDAQ: AFFX) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its CytoScan® Dx Assay. This assay is intended for the postnatal detection of DNA copy ...
Medtronic, a medical device company, has obtained the US Food and Drug Administration (FDA) approval for its CoreValve self-expanding transcatheter system. The device is designed for severe aortic stenosis patients who are too ill or ...
Tags: medical device, Medtronic
Affymetrix, a manufacturer of DNA microarrays, has obtained marketing authorization from the US Food and Drug Administration (FDA) for its Affymetrix CytoScan Dx assay that can detect chromosomal variations which may be responsible for a ...
Tags: FDA Approval, Cytoscan DX Assay
US-based Merrell Food Group, along with its manufacturing partner Rise’n Roll Specialties, is recalling ‘Crunch’N Nutter Mixed Nut’ candy due to presence of undeclared peanut allergen. The company has issued ...
Tags: Merrell Food, Candy, Peanut Allergen
Bayer HealthCare has failed to win the backing of the US FDA's Cardiovascular and Renal Drugs Advisory Committee to expand the use of its oral anticoagulant Xarelto (rivaroxaban) 2.5 mg twice daily (BID) in combination with standard ...
Tags: FDA Panel, ACS Patients
Sen. Sherrod Brown of Ohio, like many politicians in Washington, hastily reacted to a media report in his home state before researching and understanding the background and facts about safety regulations and precautions in the truck ...
Paskesz Candy Company, Brooklyn, New York is recalling its Premium Belgian Chocolate Coins Hologram .5 oz bags because they may contain traces of milk. People who have allergies to milk run the risk of serious or life-threatening allergic ...
Tags: Candy Company, milk
The U.S. Food and Drug Administration approved on Friday a first-of-its-kind blood test that can scan a child's genetic code and spot possible genetic explanations for developmental delays or intellectual disabilities. The test can ...
Google is working on contact lenses with special sensors to monitor diabetes blood sugar levels. The lens measures blood sugar levels in tears using a tiny wireless chip and miniature blood-sugar sensor embedded between two layers of soft ...
Tags: Google Crafting Contact Lenses, Google, Health, Medicine
Global standards organisation GS1 has received accreditation by the US Food and Drug Administration (FDA) as issuing agency for unique device identifiers (UDI). Global GS1 Standards meet the government’s criteria for UDI and will ...
Tags: FDA Accreditation, GS1
WASHINGTON, Jan. 15 (UPI) -- The U.S. Food and Drug Administration recommends health professionals discontinue prescribing combination drug products containing acetaminophen. The FDA recommends healthcare professionals discontinue ...
Tags: FDA, OTC, acetaminophen, acetaminophen-containing product
US-based medical device company Varian Medical Systems has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its updated ProBeam proton therapy system. Using the ProBeam system, clinicians can deliver the dose ...
Tags: Varian Medical, IMPT, ProBeam system
Illumina has entered into an agreement with Amgen to develop and commercialize a multigene, NGS-based test as a companion diagnostic for Vectibix (panitumumab), a fully human anti-EGFR monoclonal antibody therapeutic for the treatment of ...
Tags: Amgen, FDA, CE, Illumina Oncology
The Institute of Medicine (IOM) today released a 150-page summary of the two-day workshop held in August 2013 to examine the potential health impacts from consuming caffeine in dietary supplements and foods. Presenters included experts from ...
Tags: Agriculture, Food