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Latest Food and Drug Administration Stories

2014-08-22 23:06:12

More Than 5,000 Cases Now Being Handled in Massachusetts (PRWEB) August 22, 2014 According to a July 15 article in the Boston Herald, the number of lawsuits involving the use of dialysis products GranuFlo and NaturaLyte being heard in two Massachusetts courts now exceeds 5,000, the national law firm of Baron and Budd reports. The plaintiffs allege that the manufacturer of these products, Fresenius Medical Care – which also owns thousands of dialysis clinics across the United States –...

2014-08-22 16:23:24

DUBLIN, Aug. 22, 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 Rotigotine Extended-release Transdermal Film, 1 mg/24 hr, 2mg/24 hr, 3 mg/24hr, 4 mg/24 hr, 6mg/24hr, and 8 mg/24 hr. Actavis' ANDA product is a generic version of UCB's Neupro(®), which is indicated for the treatment of signs and symptoms of idiopathic Parkinson's...

2014-08-22 08:24:49

PITTSBURGH, Aug. 22, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has launched Potassium Chloride Extended-release Tablets USP, 8 mEq (600 mg) and 10 mEq (750 mg), which is the generic version of Upsher-Smith's Klor-Con®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of patients with hypokalemia, with or without metabolic...

2014-08-21 23:14:15

In four hours, John Avellanet delivers proven, practical techniques for fast, flexible, flawless inspectional handling and response. Attendees will leave the session with a complete inspection SOP and an observation closure matrix, able to prove to an investigator they’re in a “state-of-control” and, if the worst happens, go from 483 observation to a coveted Untitled Letter without ever triggering a Warning Letter. Falls Church, VA (PRWEB) August 21, 2014 Flawless FDA Inspection...

2014-08-21 23:04:09

National pharmaceutical and medical device law firm provides confidential case review to persons who were diagnosed with cancer following morcellator surgery. St. Louis, MO (PRWEB) August 21, 2014 The Onder Law Firm, nationally-renowned for its superior work in family and product liability law, announces the launch of a new Morcellator Cancer Lawsuit Center website. The website provides comprehensive information on morcellator surgery lawsuits for cancer claims, including detailed...

2014-08-21 08:28:33

ENGLEWOOD, Colo., Aug. 21, 2014 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced a delay in the data analysis of the STEP Study due to the discovery by the independent Clinical Research Organization (CRO) that the study drug (both Ampion(TM) and the placebo) were, during shipment to the clinical sites, exposed to lower temperatures than permitted by the drug specifications. http://photos.prnewswire.com/prnvar/20120516/MM09116LOGO Michael Macaluso, Ampio's...

2014-08-20 23:09:58

On August 13, the FDA announced that one lot of Sodium Chloride IV 0.9%, USP 1000 mL, by Baxter International Inc., is recalled due to the presence of particulate matter. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) August 20, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Sodium Chloride IV. The...

2014-08-20 23:08:43

The August issue of Atlantic Information Services’s Specialty Pharmacy News offers coverage of recent developments in the biosimilars specialty pharmacy segment, including the Food and Drug Administration’s recent acceptance of a biosimilar application, the first step towards approval. Washington, DC (PRWEB) August 20, 2014 Biosimilars, which are similar versions of branded biologic drugs that are approved through an abbreviated process, could reap billions in health care savings. The...

2014-08-20 23:02:11

The Firm is evaluating potential power morcellator lawsuits on behalf of women who allegedly experienced the spread of uterine sarcomas and other cancers due to uterine morcellation. New York, New York (PRWEB) August 20, 2014 As concerns regarding the health risks potentially associated with the use of power morcellators (http://www.injurybeacon.com/power-morcellator/) in gynecological surgery continue to grow, Bernstein Liebhard LLP notes that two U.S. Senators from New York are urging...

2014-08-20 23:01:14

Microscan’s upcoming Lunch & Learn event will review FDA UDI requirements and introduce methods for ensuring quality barcodes, labels, and marks that meet the demands of the FDA and the expectations of consumers. Renton, WA (PRWEB) August 20, 2014 Microscan, a global technology leader in barcode, machine vision, and lighting solutions, announces that it will host a half-day educational training event titled “Ensuring the Best Codes for FDA UDI Compliance” – presented 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
tessitura
  • The prevailing range of a vocal or instrumental part, within which most of the tones lie.
This word is Italian in origin and comes from the Latin 'textura,' web, structure.