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US FDA to Revise Regulations on Use of Healthy on Food Labels
May 13, 2016The US Food and Drug Administration (FDA) is working on revising the regulations related to the use of terms such as ‘healthy’ on food labels by manufacturers. The FDA has completed collecting inputs on how it should define ...
Tags: Food Labels, FDA
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Recent Disappointing Results for Ventricular Assist Device Companies
Nov 10, 2014Recent disappointing results for ventricular assist device companies are raising questions over adoption of the technology—which is meant to assist patients’ weakened hearts with pumping blood. HeartMate II, as shown on ...
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HeartWare Tapped a Former Boston Scientific Executive
Aug 14, 2014Implantable heart pump maker HeartWare International recently announced that it has tapped a former Boston Scientific executive as its new chief medical officer, effective September 1. Katrin Leadley, MD, was most recently chief medical ...
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Blood Glucose Test Strips Sold in These Packages Have Been Declared Misbranded by FDA
May 7, 2014Blood glucose test strips sold in these packages have been declared misbranded by FDA and should not be used. (Courtesy FDA) FDA has announced the recommendation that use of Shasta Technologies' GenStrip Glucose Test Strips be ...
Tags: FDA, Certification, Health, Medicine
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23andMe Seems to Have Backed off in Its Claims Enough to Appease The Agency.
Apr 8, 201423andMe, the Mountain View, CA–based consumer DNA testing company that got in hot water with FDA over its lack of PMA approval for its testing for various medically significant genes, now seems to have backed off in its claims enough ...
Tags: Health, Medicine, FDA, certification
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The Lake Forest Has Spent More Than $1 Billion Across Its Global Operations.
Mar 14, 2014Just when Hospira Inc.'s Rocky Mount, NC–manufacturing facility was starting to think it could breathe a little easier, FDA delivered another Warning Letter. The Lake Forest, IL-–based manufacturer of pharmaceuticals, other ...
Tags: medical device, Health, Medicine
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FDA Publishes Eight Warning Letters Issued to Food Manufacturers and Processors
Feb 27, 2014The U.S. Food and Drug Administration published eight warning letters last week that were issued to food manufacturers and processors mainly in February. Reyskens Dairy in Custer, OH, and Ed Vander Woude Dairy in San Jacinto, CA, received ...
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The U.S. Food and Drug Administration Has Published Nine Warning
Feb 27, 2014The U.S. Food and Drug Administration has published nine warning letters it issued to food manufacturers and processors at the end of January and the start of February. Orth Farms of Eaton, NY, B & E Dairy of Barstow, CA, and Hillegass ...
Tags: FDA, Warning Letters, Food Manufacturers
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The U.S. Food and Drug Administration Issued 11 Warning Letters
Feb 13, 2014In the first month of 2014, the U.S. Food and Drug Administration issued 11 warning letters to food manufacturers and processors. The first two warning letters of the year were delivered to a seafood processing facility in Hawaii and a ...
Tags: FDA, FOOD SAFETY
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Refuse to Korean Owned Starkist Tuna
Feb 10, 2014After crossing 3,400 miles of the Pacific Ocean last year to inspect a tuna canneryon American Samoa,a U.S.Food and Drug Administration(FDA)inspector asked for copies of some records from the StarKist Co. "Charlie the Tuna,"the company's ...
Tags: Starkist Tuna, tuna cannery
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First Warning Letters of 2014 Issued by FDA Were Delivered to Seafood Processing Facility
Jan 21, 2014The 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
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Concussions Can't Be Prevented, Treated or Cured with Dietary Supplements
Jan 13, 2014Concussions can't be prevented, treated or cured with dietary supplements, according to the U.S. Food and Drug Administration. The agency issued a warning against these products in response to a number of false claims, including promises ...
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Topol Has Cred When It Comes to Patient Safety
Dec 11, 2013A "misfire" is the way Eric Topol, MD, describes 23andMe's recent regulatory tussle with the FDA, which resulted in the Silicon Valley-based company halting sales for now of its health-related genetic test analysis. Speaking with MPMN ...
Tags: 23andme, FDA, regulatory tussle
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23andMe Says It Will Stop Selling Health-Related Genetic Test Analysis
Dec 6, 2013Under pressure from the FDA, 23andMe says it will stop selling health-related genetic test analysis until it has resolved its dispute with the federal regulatory agency. "We remain firmly committed to fulfilling our long-term mission to ...
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23andMe Halted All Marketing Last Week in Accordance with The FDA's Letter.
Dec 4, 2013More than a week after the FDA told 23andMe to stop marketing its Personal Genomic Service tests, the Mountain View, CA–based company says it is complying. "23andMe halted all marketing last week in accordance with the FDA’s ...
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