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Latest Food and Drug Administration Stories

2014-09-05 08:23:21

PITTSBURGH, Sept. 5, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has launched Ibandronate Sodium Injection, 1 mg (base)/mL, packaged in 3 mg (base)/3 mL pre-filled glass syringes, which is the generic version of Hoffmann-La Roche's Boniva® Injection. 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 osteoporosis in...

2014-09-04 12:30:14

WINNETKA, Calif., Sept. 4, 2014 /PRNewswire/ -- Green Cures & Botanical Distribution Inc. (OTC Pink: GRCU) ("Green Cures") announced today that it is now working with Florida-based Nutritional Products International and InHealth Media for the distribution and marketing of Green Cures' nutritional, sports, hemp-infused and body care products across the U.S. market. "Our first marketing strategy is to promote and enhance our brands in targeted geographic locations, including...

2014-09-04 12:21:31

Conference attendees get chance to discuss visibility, collaboration and brand protection challenges with the experts MARLTON, N.J., Sept. 4, 2014 /PRNewswire/ -- Acsis Inc., the market leader for supply chain visibility, brand protection and serialization solutions, announced the company will be attending two major pharmaceutical industry conferences in September - PDA/FDA Joint Regulatory Conference, September 8-9 at the Renaissance Hotel, Washington DC, Booth # 58; and LogiPharma,...

2014-09-04 08:30:00

LAUSANNE, Switzerland, September 4, 2014 /PRNewswire/ -- Debiopharm Group(TM)(Debiopharm), a Swiss-based global biopharmaceutical company developing prescription drugs that target unmet medical needs including anti-infective and oncology therapeutics as well as companion diagnostics, today announced that the US Food and Drug Administration (FDA) has designated its anti-infectious agent Debio 1450 as a Qualified Infectious Disease Product (QIDP) for the treatment of acute...

2014-09-04 08:26:07

REDWOOD CITY, Calif., Sept. 4, 2014 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced the publication of the results of a study to evaluate patient satisfaction with a novel sublingual sufentanil patient-controlled analgesia (PCA) system compared to the standard intravenous PCA for the management of...

2014-09-03 23:14:59

On August 26, Mars Petcare US announced the recall of specific bags of Pedigree Adult Complete Nutrition dry dog food products due to the possible presence of a foreign material. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) September 03, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Pedigree...

2014-09-03 23:11:45

Pew, Blue Cross Blue Shield Association, and MDEpiNet report captures recommendations of 30 diverse health care experts Washington, DC (PRWEB) September 03, 2014 Three organizations today proposed wide-ranging recommendations on the development of registries to address the country’s lack of a robust national system for assessing the safety and effectiveness of medical devices. Registries, which contain information on patients treated with specific medical devices, could fill this gap...

2014-09-03 12:27:51

MUMBAI, India, September 3, 2014 /PRNewswire/ -- Now, Chinese regulations on medical devices are undergoing earthshaking changes. China's new leaders have recognized that the regulations for supervision and administration of medical devices are far from perfect along with rapid economic and population growth over the past three decades. Chinese state council issued the latest "Regulations for the Supervision and Administration of Medical Devices" to try to completely change...

2014-09-03 12:23:00

WASHINGTON, Sept. 3, 2014 /PRNewswire-USNewswire/ -- An advisory committee to the Food and Drug Administration was told that unreasonable FDA restrictions on healthcare use of safe and effective antibacterial ingredients could jeopardize the safety of patients and healthcare workers alike. http://photos.prnewswire.com/prnvar/20140313/DC83006LOGO In a presentation to FDA's Nonprescription Drugs Advisory Committee (NDAC) organized by the American Cleaning Institute (ACI), health...

2014-09-03 08:34:15

SAN DIEGO, Sept. 3, 2014 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Halozyme's program investigating PEGPH20 (PEGylated recombinant human hyaluronidase) in combination with gemcitabine and nab-paclitaxel for the treatment of patients with metastatic pancreatic cancer to demonstrate an improvement in overall survival. The Fast Track designation process was developed...


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
omphalos
  • The navel or umbilicus.
  • In Greek archaeology: A central boss, as on a shield, a bowl, etc.
  • A sacred stone in the temple of Apollo at Delphi, believed by the Greeks to mark the 'navel' or exact center-point of the earth.
'Omphalos' comes from the ancient Greek.
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