Quantcast
Last updated on April 17, 2014 at 17:30 EDT

Latest Food and Drug Administration Stories

2014-03-28 23:25:44

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 Chicago, IL (PRWEB) March 28, 2014 The prescription drug safety center DrugRisk.com is announcing updated legal news on the site for patients taking the blood thinner Pradaxa. Recent court documents show a federal court has scheduled the first lawsuit alleging the drug caused internal bleeding injury or death to start in...

2014-03-28 16:22:54

DUBLIN, March 28, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that the United States Court of Appeals for the Federal Circuit has reversed a lower court ruling that Actavis' generic version of Shire's Lialda(®) (mesalamine extended-release tablets) infringes United States Patent No. 6,773,720 (the '720 Patent). The Appeals Court found that the U.S. District Court for the Southern District of Florida did not correctly construe the claims of the '720 Patent, and...

2014-03-28 16:22:39

TAMPA, Fla., March 28, 2014 /PRNewswire-USNewswire/ -- Top officials from the US FDA will meet with ISPE Members and other pharmaceutical industry leaders to discuss compliance trends and identify practical solutions for modern quality systems, technology transfer, metrics implementation and other relevant topics during the third annual ISPE-FDA CGMP Conference, taking place 2 - 4 June in Baltimore, Md. USA. The conference will explore industry hot topics in an ongoing conversation between...

2014-03-27 23:33:17

According to the CDC, roughly 3,000 people die each year due to foodborne diseases. In light of the recent updated inspection and compliance mandates under the FDA Food Safety Modernization Act, WetKeys has seen a significant increase of orders for its waterproof and washable computer keyboards to be used in food processing and beverage bottling plants. Atlanta, GA (PRWEB) March 27, 2014 The FDA Food Safety Modernization Act is currently updating its inspection and compliance mandates...

2014-03-27 23:29:03

This workshop, chaired by internationally renowned expert Fubin Wu and featuring three FDA experts, has been specifically designed to provide devicemakers with industry best practices to achieve compliance and effectively assure medical device software safety. In two days of intensive sessions, attendees will be brought up to date on the FDA’s latest research on medical device software best practices, software risk management related standards and guidances and key success factors for...

2014-03-27 23:02:53

The Firm is representing numerous GranuFlo lawsuit clients who allegedly suffered sudden and catastrophic heart problems following the administration of GranuFlo or NaturaLyte Dialysis Concentrates. New York, NY (PRWEB) March 27, 2014 Hundreds of GranuFlo lawsuits (http://www.thegranuflolawsuit.com) filed in the wake of the 2012 recall of GranuFlo and NaturaLyte dialysis concentrates continue to move forward in courts throughout the country, Bernstein Liebhard LLP reports. According to...

2014-03-27 16:24:59

SCHAUMBURG, Ill., March 27, 2014 /PRNewswire-USNewswire/ -- The American Veterinary Medical Association (AVMA) applauds recent actions taken by the U.S. Food and Drug Administration (FDA) that will allow for greater veterinary oversight of the use of antimicrobials in food animals. "This move by the FDA is one that we have worked toward for some time now, and we are pleased that veterinarians will be even more involved in overseeing the use and administration of antimicrobials on the...

2014-03-27 08:34:44

Provides access for dialysis patients; complementary to HeRO® Graft ATLANTA, March 27, 2014 /PRNewswire/ -- CryoLife, Inc. (NYSE: CRY), a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that it has acquired the exclusive worldwide distribution rights for the ProCol Vascular Bioprosthesis ("ProCol") from Hancock Jaffe Laboratories, Inc. In addition, beginning 24 months after execution of the agreement, CryoLife has the right to...

2014-03-27 08:34:36

AVP-825 relies on novel closed palate Breath Powered(TM) drug delivery technology YARDLEY, Pa., March 27, 2014 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for AVP-825, an innovative closed-palate Breath Powered(TM) investigational drug-device combination product for the acute treatment of migraine. As previously reported, the 505(b)(2) NDA for AVP-825 includes clinical data developed by OptiNose including a pivotal phase...

2014-03-27 08:33:44

Jury awards Mylan $106.7 million in damages PITTSBURGH, March 27, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that, after a trial in the United States District Court for the District of New Jersey, a jury returned a verdict in favor of Mylan in its breach of contract lawsuit against GlaxoSmithKline (GSK) relating to Paroxetine Hydrochloride Extended-release (ER) Tablets. The jury decided that GSK owes Mylan $106.7 million in damages. Mylan's claims were based...


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...

More Articles (2 articles) »