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Latest Food and Drug Administration Stories

2014-09-03 08:34:10

Company CEO to present at both the Rodman & Renshaw Global Investment Conference and Aegis Capital 2014 Healthcare and Technology Conference in September JERUSALEM, September 3, 2014 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (http://www.oramed.com [http://c/Users/Aviva - Oramed/EFN Synced Tool/.CORPORATE/Public Relations/PressReleases/Press Releases/2014/NEW RELEASES - checking/www.oramed.com ] ), a clinical-stage pharmaceutical company focused on the...

2014-09-03 08:34:03

Features more than 70 in-house counsel, judges, government officials and industry experts in product liability litigation NEW YORK, Sept. 3, 2014 /PRNewswire/ -- American Conference Institute (ACI) is pleased to announce the agenda for its 19(th) Annual Drug and Medical Device Litigation on December 8-10 in New York City. Agenda is now available online. Photo - http://photos.prnewswire.com/prnh/20140903/142346 Featuring 3 new Co-Chairs: Sonia Arnold Counsel-Litigation and Legal Compliance,...

2014-09-03 08:32:21

SAN DIEGO, Sept. 3, 2014 /PRNewswire/ -- Ajinomoto Althea, Inc. ("Althea"), a leading provider of biopharmaceutical contract development and manufacturing services announced today that it has officially received its European GMP certificate issued by the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA conducted an on-site inspection on June 19, 2014 that yielded no critical or major observations. This certification provides clearance to Althea to test commercial...

2014-09-02 23:07:10

Dr. Benlhabib has developed cutting-edge methods to formulate modern-day solutions to hair loss based on traditional medicinal plant therapy. Moroccan Eco-Biologics seek support for Indiegogo campaign to conduct clinical trials to gain FDA approval for their products. St. Paul, MN (PRWEB) September 02, 2014 Moroccan Eco-Biologics’ new one-of-a-kind Vitality Hair Recovery products have been refined and specially formulated, while preserving the foundation of all natural Moroccan plant...

2014-09-02 20:24:39

CBR International's Scientific Experts Supporting Mapp Biopharmaceutical Pertaining to ZMAPP(TM) BOULDER, Colo., Sept. 2, 2014 /PRNewswire/ -- Dr. Jeanne M. Novak, President and CEO of Boulder, Colorado-based CBR International Corp.(®), a full-service biopharmaceutical product, clinical, medical device and regulatory development and compliance group, has been invited by Dr. Larry Zeitlin, President of Mapp Biopharmaceutical to attend the World Health Organization's Investigational...

2014-09-02 16:24:25

AUSTIN, Texas, Sept. 2, 2014 /PRNewswire/ -- On July 31, the Food and Drug Administration sent its 60-day notice to Congress that it is moving forward to regulate laboratory-developed tests (LDTs). The clock is now ticking down the minutes until laboratories throughout the U.S. will need to comply with a host of new requirements. Although some medical laboratories may subscribe to the strategy to simply sit back and wait for the FDA to put guidelines in place, it's widely acknowledged that...

2014-09-02 08:29:52

SAN DIEGO, Sept. 2, 2014 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that the US Food and Drug Administration (FDA) has granted orphan drug status to APD811 for the treatment of pulmonary arterial hypertension. "The FDA Office of Orphan Products Development (OOPD) evaluates scientific and clinical data submissions from sponsors to identify and designate drug candidates that could potentially treat rare diseases to help advance the evaluation and...

2014-09-02 08:29:18

-- Company Completes Final Preclinical Toxicology Study and Prepares to File Investigational New Drug (IND) in 2H 2014 -- ROCKVILLE, Md., Sept. 2, 2014 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases, announced today positive results from its final preclinical toxicology study of SYN-004. Per U.S. Food and Drug Administration (FDA)...

2014-09-01 23:03:48

On August 28, the FDA announced that certain lots of DePuy Synthes Craniomaxillofacial Distraction System are recalled (Class I) as the device may reverse directions after surgery. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) September 01, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on DePuy Synthes...

2014-08-31 23:03:49

Datex Pharmaceutical Software now includes a suite of features which enables compliance of the new FDA regulation, the Drug Quality Security Act (DQSA). Clearwater FL (PRWEB) August 31, 2014 Datex Pharmaceutical Software now includes a suite of features which enables compliance of the new FDA regulation, the Drug Quality Security Act (DQSA). The FDA Drug Quality and Security Act (DQSA) was signed into law in late 2013. Established to address threats to patient safety and security, the...


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
jument
  • A beast of burden; also, a beast in general.
'Jument' ultimately comes from the Latin 'jugum,' yoke.
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