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Last updated on April 21, 2014 at 9:20 EDT

Latest Food and Drug Administration Stories

2014-03-05 23:28:24

http://www.DrugNews.net is the web’s premier source for prescription device warnings, research, side effects and legal news. Visit the DrugNews Center today. Chicago, IL (PRWEB) March 05, 2014 The prescription drug safety center DrugNews.net is announcing new information on the site for patients taking the blood thinner Pradaxa. A new report shows a research institute responsible for testing the drug prior to FDA approval has been named in lawsuits alleging it caused internal...

2014-03-05 23:27:46

The DrugRisk Center is the largest source on the Web for information on prescription drug research, side effects and legal news. Visit http://www.DrugRisk.com New York, NY (PRWEB) March 05, 2014 The prescription drug safety center DrugRisk.com is announcing new information on the site for patients using testosterone replacement therapy drugs. The FDA was recently petitioned to add warnings to the drug labels* after studies and lawsuits alleged they may cause heart attacks or stroke**....

2014-03-05 23:02:23

The Firm is evaluating Pradaxa lawsuits on behalf of patients who allegedly suffered serious and life-threatening internal bleeding due to Pradaxa. New York, New York (PRWEB) March 05, 2014 As thousands of Pradaxa lawsuits (http://www.pradaxalawsuithelp.com/ ) continue to move forward in federal court, Bernstein Liebhard LLP notes that newly unsealed court documents indicate that Boehringer Ingelheim did not inform federal regulators of a data analysis that indicated Pradaxa was...

2014-03-05 23:01:49

Dr. Sardo, Board Certified plastic surgeon in La Jolla, CA, is pleased to announce the use of LATISSE®. This clinically tested, FDA approved medical breakthrough helps grow and improve the volume of natural eyelashes, freeing women of the daily dependence on mascara and false eyelashes. La Jolla, CA (PRWEB) March 05, 2014 Dr. Marilyn Sardo, Board Certified plastic surgeon in La Jolla, California, proudly offers LATISSE® to her patients as a proven method to achieve longer,...

2014-03-05 14:41:49

An analysis of nearly 24,000 active human research clinical trials found that between 5 percent and 16 percent fall into a regulatory gap and are not covered by two major federal regulations, according to a study in the March 5 issue of JAMA. These trials studied interventions other than drugs or devices (e.g., behavioral, surgical). The primary federal human subjects protections (HSP) policies in the United States, including requirements for institutional review board review and informed...

2014-03-05 12:27:41

FALLS CHURCH, Va., March 5, 2014 /PRNewswire-iReach/ -- HIPAA/HITECH Compliance Strategies for Medical Device Manufacturers (Photo: http://photos.prnewswire.com/prnh/20140305/MN76532) **FDAnews Webinar** March 20, 2014 -- 1:00 p.m. - 2:30 p.m. EDT www.fdanews.com/HIPAAsecurity Medical Devices Could Be Unwittingly Violating HIPAA Electronically Protected Health Information Standards (ePHI) -- HHS OIG's 2014 Work Plan Announces Research Initiative to Find Out As concerns mount about medical...

2014-03-04 23:32:12

FGXPress PowerStrips™ are the first of their kind Network Marketing Product that can be sold anywhere in the world. PowerStrips™ are a patented, doctor formulated and FDA Class I Medical Device for the temporary relief of pain. New York, New York (PRWEB) March 04, 2014 The Network Marketing Business has elevated to a new level with FGXPress PowerStrips™. Goldman Small Cap Research, a stock market research firm focused on the small cap and micro cap sectors, notes in a recent article...

2014-03-04 16:26:01

PLEASANTON, Calif., March 4, 2014 /PRNewswire/ -- On March 4, 2014, Thoratec Corporation initiated a voluntary worldwide Medical Device Correction in order to update its labeling and training materials for the HeartMate II(®) LVAS Pocket System Controller (the "Pocket Controller"). This safety advisory is being issued because some patients and caregivers have experienced difficulties with the process of changing from a primary system controller to their backup system controller. These...

2014-03-04 12:27:01

Parents Pushing FDA for Accelerated Approval of Safe and Effective Drug WASHINGTON, March 4, 2014 /PRNewswire-iReach/ -- After calling on the FDA directly to approve a breakthrough therapy for Duchenne Muscular Dystrophy, and appealing to Congress on behalf of the thousands of children facing this fatal genetic disease, concerned families have launched a national campaign and petition drive called "The Race to Yes" at TheRacetoYes.org to underscore the urgent need for accelerated...

2014-03-04 08:33:11

BELLEVILLE, ON, March 4, 2014 /PRNewswire/ - Bioniche Life Sciences Inc. (TSX: BNC) announced today key corporate updates: -- The establishment of Monday, April 14, 2014 as the date of the Shareholder Meeting for consideration of the C$61 million acquisition offer for Bioniche's Animal Health business; -- The scheduling of a Shareholder Conference Call on Thursday, March 13, 2014, with Bioniche CEO, Dr. Michael Berendt, to...


Latest Food and Drug Administration Reference Libraries

Flavr Savr
2013-10-03 09:43:32

Flavr Savr, also known as CGN-89564, a genetically modified tomato, was the first commercially grown genetically engineered food to be granted a license for human consumption. It was produced by the Californian company Calgene, and submitted to the U.S. Food and Drug Administration in 1992. On May 18, 1994, the FDA completed its evaluation of the Flavr Savr tomato and the usage of APH(3’)II, concluding that the tomato “is as safe as tomatoes bred by conventional means” and “that the...

Chilean Sea Bass, Dissostichus eleginoides
2013-01-12 08:49:28

The Chilean sea bass is the North American name for the Patagonian toothfish. The Chilean sea bass name derived in 1977 from Lee Lantz, a fish wholesaler looking for a more attractive name for the American fish market. In 1994 the Food and Drug Administration (FDA) accepted the Chilean sea bass as an alternative name for the Patagonian toothfish. This species is native to the southern Pacific, Atlantic, and Indian Oceans, around seamounts and continental shelves in the colder waters. The...

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