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Latest Food and Drug Administration Stories

2014-07-09 16:28:44

BASKING RIDGE, N.J., July 9, 2014 /PRNewswire/ -- Regado Biosciences, Inc., (NASDAQ: RGDO) today announced that, further to their decision to voluntarily pause enrollment in their REGULATE-PCI trial, the United States Food and Drug Administration (FDA) informed the company today that a clinical hold has been placed on all patient enrollment and dosing of either study drug in the ongoing Phase 3 REGULATE-PCI trial. According to the FDA, this action was taken to formalize the...

2014-07-09 16:28:10

Study calls for more focus on long-term outcomes in pediatric trials of drugs intended for chronic use BOSTON, July 9, 2014 /PRNewswire-USNewswire/ -- Over the last 60 years, the U.S. Food and Drug Administration (FDA) approved 20 medications for attention deficit/hyperactivity disorder (ADHD) based on clinical trials that were not designed to study their long-term efficacy and safety or to detect rare adverse events, researchers at Boston Children's Hospital report today in PLOS...

2014-07-09 08:27:39

CRANBURY, N.J., July 9, 2014 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE MKT: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application Serial Number 13/910,422 (the '422 application). The application includes...

2014-07-08 23:14:36

On July 2, the FDA announced that Medtronic Duet External Drainage and Monitoring System is recalled (Class I). In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) July 08, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Medtronic Duet External Drainage and Monitoring System. The FDA informed on July 2,...

2014-07-08 23:08:08

Matters Involving Ongoing Litigation to Be Discussed DALLAS (PRWEB) July 08, 2014 Parties involved in lawsuits regarding the anti-psychotic drug Risperdal are scheduled to meet in the Philadelphia Court of Common Pleas to hold a conference to discuss moving litigation forward, the national law firm of Baron and Budd reports. The plaintiffs in the lawsuits accuse Janssen Pharmaceuticals, as well as parent company Johnson & Johnson, of allegedly failing to properly warn users of...

2014-07-08 23:05:03

Have you experienced intestinal problems after taking Benicar, Azor or Tribenzor? There are current lawsuits being filed on behalf of victims. Toledo, OH (PRWEB) July 08, 2014 The U.S. Food and Drug Administration (FDA) issued a warning on July 3, 2013, that the blood pressure drug, olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause serious intestinal problems known as sprue-like enteropathy. The FDA also required changes to the labels of...

2014-07-08 23:03:02

PharmacyChecker.com published almost 2000 consumer comments showing that Americans are concerned about new federal regulations expanding the authority of the FDA to destroy safe drug imports for personal use. PharmacyChecker.com submitted public comments to the FDA, offering suggestions that would protect access by Americans to safe and affordable prescription drugs. White Plains, NY (PRWEB) July 08, 2014 PharmacyChecker.com announced the publication on its website of almost 2000 comments...

2014-07-08 23:00:26

http://www.DrugNews.net is the largest source for prescription device warnings, research, side effects and legal news. Visit the DrugNews Center today. Nashville, TN (PRWEB) July 08, 2014 The birth control safety center at DrugNews.net is alerting women using the Mirena IUD contraceptive of new information on the site. A recent lawsuit alleges the device caused a Kentucky woman to suffer vision problems from pseudotumor cerebri*. DrugNews is a free resource created to give those using...

2014-07-08 16:25:34

DUBLIN, July 8, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Dalfampridine Extended-release Tablets, 10 mg. Actavis' ANDA product is a generic version of Acorda Therapeutics' Ampyra(®), which is indicated as a treatment to improve walking in patients with multiple sclerosis. Acorda Therapeutics, Inc. filed suit against Actavis on...

2014-07-08 12:28:45

CHARLOTTE, N.C., July 8, 2014 /PRNewswire/ -- UniStrip Technologies, LLC of Charlotte NC has filed an antitrust lawsuit in the Los Angeles federal court against LifeScan, Inc., a Johnson & Johnson Company, for violations of the Sherman and Clayton Acts. In November, 2013 the FDA cleared UniStrip to market test strips that are compatible with four of LifeScan's OneTouch Ultra blood glucose meters. The key to UniStrip's success would be its highly accurate strips, as cleared by...


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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Word of the Day
baudekin
  • A rich embroidered or brocaded silk fabric woven originally with a warp of gold thread.
'Baudekin' seems to be an alternative form of 'baldachin,' from the Italian 'Baldacco,' Baghdad, the city where the material was made.
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