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Latest Food and Drug Administration Stories

2014-06-30 08:29:59

DUBLIN, June 30, 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 Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablets, Eq, 1.4 mg/0.36 mg and 5.7 mg/1.4 mg Base. Actavis' ANDA product is a generic version of Orexo's Zubsolv(®), which is a partial opioid agonist indicated for the maintenance treatment of...

Exoskeleton System ReWalk Approved For Sale In The US
2014-06-29 04:41:34

Alan McStravick for redOrbit.com - Your Universe Online This year's FIFA World Cup, being played in Brazil, is a quadrennial event that captures the attentions of a staggering majority of the people that live on this planet. Excusing the pun, the event kicked off by celebrating a revolutionary advancement in paraplegic mobility technology made possible by work done by one of Brazil's native sons, Dr. Miguel A. L. Nicolelis, MD, PhD. Heading up the Walk Again Project, Nicolelis explained...

2014-06-27 23:10:35

In May 2014, the FDA released a draft guidance that covers the selection and approval process for proposed names of both prescription and nonprescription human drugs and biologics. FDAnews has teamed with drug-naming expert Dr. Susan Proulx to present a 90-minute webinar that will look closely at the draft guidance and its recommended 4-step process. Falls Church, VA (PRWEB) June 27, 2014 Choosing the Right Drug Name: How to Increase Your Chances for Approval **FDAnews Webinar** July...

2014-06-27 23:08:11

Roger Denton of Schlichter, Bogard & Denton, LLP reports that a recent lawsuit alleges that the blood thinning medication Xarelto® is linked to serious and life-threatening bleeding events. St. Louis, MO (PRWEB) June 27, 2014 According to a recent lawsuit filed in the Philadelphia County Court of Common Pleas (Stuntebeck v. Janssen Research & Development LLC et al, Case No.140201754), the anticoagulant drug Xarelto® (rivaroxaban) is alleged to cause serious and...

2014-06-27 23:08:09

On June 23, the FDA issued a safety communication on mammography problems at Big Sky Diagnostic Imaging, LLC in Butte, Montana. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) June 27, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on safety alerts for mammograms. The FDA issued a safety communication on...

2014-06-27 23:06:11

Supply chain software developer Datex Corporation announced new pharmaceutical editions of its award winning warehouse management software for the pharmaceutical, medical device and life sciences industries. Clearwater, FL (PRWEB) June 27, 2014 Supply chain software developer Datex Corporation announced new pharmaceutical editions of its award winning warehouse management software for the pharmaceutical, medical device and life sciences industries. The new pharmaceutical software...

2014-06-27 23:02:29

The Firm is investigating morcellator lawsuits on behalf of women who allegedly experienced the spread of uterine sarcomas and other cancers due to the use of power morcellators in gynecological surgeries. New York, New York (PRWEB) June 27, 2014 As it continues its investigation of hysterectomy cancer lawsuits (http://www.gynecaremorcellatorlawsuit.com/) on behalf of women who allegedly experienced the spread of uterine cancers due to power morcellators, Bernstein Liebhard LLP notes that...

2014-06-27 21:43:11

BMJ-British Medical Journal US regulator has taken 84 sponsors/investigators/institutions to task over 7 years Failure to protect patient safety and poor record keeping were among the most common violations picked up by the US regulator in the running of clinical trials over a period of seven years, reveals a study published online in the Journal of Medical Ethics. The study authors reviewed the content of 84 first warning letters issued by the United States Food and Drug...

2014-06-27 12:25:58

Receives first-to-file FDA approval, with 180-day marketing exclusivity for generic version in the treatment of hypertension and heart failure NEW BRUNSWICK, N.J., June 27, 2014 /PRNewswire/ -- Ohm Laboratories, Inc. (Ohm), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that Ohm has received approval from the U.S. Food and Drug Administration to manufacture and market Valsartan 40 mg, 80 mg, 160 mg, and 320 mg tablets on an exclusive basis....

2014-06-27 08:23:26

NEW YORK, June 27, 2014 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA), based in Silver Spring, Maryland provides a variety of public health services in the United States through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter (OTC) pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics and veterinary...


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
glogg
  • Scandinavian punch made of claret and aquavit with spices and raisins and orange peel and sugar.
This word comes from the Swedish 'glogg,' which is an alteration of 'glodgat,' mulled (wine).
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