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Latest Food and Drug Administration Stories

2014-10-22 12:22:58

PITTSBURGH, Oct. 22, 2014 /PRNewswire-iReach/ -- Gateway Analytical announced today that they will be presenting on chemically-specific particle analysis in addition to exhibiting at the upcoming Bioequivalence: Intersection between Science & Regulatory Conference in San Diego, California, on November 5(th)-6(th). The focus of the Bioequivalence Conference is to help bridge the gap between the scientific community and regulatory agencies in order to safely bring a new drug to...

2014-10-22 08:32:34

Monitors Proper Device Use and Enhances Patient Compliance SAN DIEGO, Oct. 22, 2014 /PRNewswire/ -- AVACEN Medical announced today that its AVACEN 100 Class II medical device received 510 (k) OTC clearance by the U.S. Food and Drug Administration. This clearance allows the AVACEN 100 to be marketed over the Internet for: the temporary relief of joint pain associated with arthritis; muscle spasms; and minor strains and sprains. Logo - http://photos.prnewswire.com/prnh/20141021/153513...

2014-10-21 23:13:16

Lawrence Livermore National Laboratory researchers recently published an article in PLOS ONE detailing the use of supercomputers to link proteins to drug side effects. The research showed their computational model of predicting side effects to be more predictive than current statistical methods in two cases, and the calculations also predicted new potential side effects. Livermore, California (PRWEB) October 21, 2014 New medications created by pharmaceutical companies have helped millions...

2014-10-21 23:13:07

On October 15, the FDA announced that certain lots of LifeCare Flexible Intravenous Solutions by Hospira, Inc. are recalled due to potential for leakage. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) October 21, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on LifeCare Flexible Intravenous Solutions....

2014-10-21 16:28:41

First-Ever Product Submission for LAL Deficiency LEXINGTON, Mass., Oct. 21, 2014 /PRNewswire/ -- Synageva BioPharma Corp. (Synageva) (NASDAQ: GEVA), a biopharmaceutical company developing therapeutic products for rare disorders, announced today the start of a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for sebelipase alfa as a treatment for patients with lysosomal acid lipase deficiency (LAL Deficiency), a rare genetic...

2014-10-21 16:28:26

DUBLIN, October 21, 2014 /PRNewswire/ -- Research and Markets ( http://www.researchandmarkets.com/research/fp9gxz/global_potential) has announced the addition of the "Global Potential Analysis of Ebola drug and Vaccines Market (Pipeline analysis, Drugs, Vaccines, and Geography) through 2020" [http://www.researchandmarkets.com/research/fp9gxz/global_potential ] report to their offering. (Logo: http://photos.prnewswire.com/prnh/20130307/600769 ) The new report...

2014-10-21 16:27:47

LONDON, Oct. 21, 2014 /PRNewswire/ -- Executive SummaryChina's regulatory framework for medical devices is undergoing radical changes. The country's new leaders have recognized that the regulations for supervision and administration of medical devices are far from perfect along with rapid population growth and thriving economy over the past 30 years. Chinese state council issued the latest "Regulations for the Supervision and Administration of Medical Devices" on February 12, 2014,...

2014-10-21 12:32:03

FALLS CHURCH, Va., Oct. 21, 2014 /PRNewswire-iReach/ -- UDI:It Won't Wait Until You Are Ready **Presented by FDAnews and Ombu Enterprises** Nov. 11, 2014 - Chicago, IL Nov. 13, 2014 - Waltham, MA www.fdanews.com/UDIWorkshopILMA Photo - http://photos.prnewswire.com/prnh/20141021/153319 One Unique Device Identification (UDI) deadline has come and gone. Other deadlines loom in the coming months. Don't risk a 483, warning letter or unhappy customers. The first UDI deadline for Class 3 device...

2014-10-21 08:33:30

Universal needle-free reconstitution and transfer system now available for use in hospitals EXTON, Pa., Oct. 21, 2014 /PRNewswire/ -- West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, has received 510(k) clearance of the Vial2Bag® DC device from the United States Food and Drug Administration, and also the CE Mark for the European Union. http://photos.prnewswire.com/prnvar/20131029/NE05658LOGO The Vial2Bag...

2014-10-20 23:09:15

On October 10, the FDA advised consumers not to purchase or use Sit and Slim II due to hidden drug ingredients. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) October 20, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Sit and Slim II. The FDA advised consumers on October 10 not to purchase or use Sit...


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
conjunto
  • A style of popular dance music originating along the border between Texas and Mexico, characterized by the use of accordion, drums, and 12-string bass guitar and traditionally based on polka, waltz, and bolero rhythms.
The word 'conjunto' comes through Spanish, from Latin coniūnctus, past participle of coniungere, to join together; see conjoin