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Latest Food and Drug Administration Stories

2014-08-13 23:09:49

On August 7, the US FDA informed consumers that two lots of RegeneSlim appetite control capsules, by Regeneca Worldwide, were recalled due to presence of DMAA. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) August 13, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on appetite control capsules. The FDA...

2014-08-13 16:26:02

THOUSAND OAKS, Calif., Aug. 13, 2014 /PRNewswire/ -- Amgen (NASDAQ:AMGN) initiated a voluntary recall on June 26, 2014 for nine packaged lots of Aranesp(®) (darbepoetin alfa) (500 mcg) prefilled syringes from non-U.S. distributors, wholesalers and a number of hospital pharmacies due to the potential presence of cellulose and/or polyester particles observed in a small number of syringes during a routine quality examination. Lots 1042847, 1044141A, 1044141C, 1044141D, 1046891A, 1046891B,...

2014-08-13 12:28:06

An Intravenous Fat Emulsion Approved for Adult and Pediatric Patients BETHLEHEM, Pa., Aug. 13, 2014 /PRNewswire/ -- B. Braun Medical Inc. (B.Braun), a leader in infusion therapy and pain management, announced today that it has received U.S. Food and Drug Administration (FDA) approval of Nutrilipid(®) 20% (I.V. fat emulsion) for parenteral nutrition therapy in adult & pediatric patients. Nutrilipid 20% is indicated as a source of calories and essential fatty acids for parenteral...

2014-08-13 08:29:24

WASHINGTON, Aug. 13, 2014 /PRNewswire/ -- The National Organization for Rare Disorders (NORD) today announced the agenda for the Rare Diseases and Orphan Product Breakthrough Summit, to be held October 21-22, 2014 at the Hilton Mark Center in Alexandria, VA. Photo - http://photos.prnewswire.com/prnh/20140812/135518 This annual event is the innovative hub for all stakeholders in the rare disease and orphan products community - providing an educational platform for pharmaceutical, biotech,...

2014-08-12 23:10:30

On August 9, Cubist Pharmaceuticals, Inc. announced the recall of certain lots of Cubicin (daptomycin for injection) 500 mg 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 12, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Cubicin (daptomycin for...

2014-08-12 23:09:28

In support of the Alliance for Clinical Research Excellence and Safety (ACRES) global collaborative model, industry stakeholders have pledged more than $102M in technologies and services to transform the clinical research enterprise and accelerate medicines development, enhancing quality, safety and long-term industry sustainability. (PRWEB) August 12, 2014 Following the recent meeting of a multi-sector global stakeholder consultation on clinical research site-excellence, strategic allies...

2014-08-12 08:31:32

Innovative OncoSolutions to Distribute Leading Closed System Transfer Devices in Canada; Announcement Comes Shortly After FDA Clears Device under ONB Product Code PORT WASHINGTON, New York and OAKVILLE, Ontario, August 12, 2014 /PRNewswire/ -- Equashield (http://www.equashield.com), a leading provider of Closed System Transfer Device [http://www.equashield.com ]s (CSTDs) for hazardous drugs, announced today a new exclusive partnership with Canadian distributor Innovative...

2014-08-12 08:30:30

SAN DIEGO, Aug. 12, 2014 /PRNewswire/ -- Trovagene, Inc. (NASDAQ: TROV), a developer of cell-free molecular diagnostics, announced today that K. Peter Hirth, Ph.D., has joined the Company's Scientific Advisory Board. Dr. Hirth is an industry leader and innovator with over 30 years of biotechnology and pharmaceutical discovery and development experience. A pioneer in the field of personalized medicine, Dr. Hirth led the organizations that developed both Sutent(®) and Zelboraf(®);...

2014-08-12 08:29:19

BEMA Buprenorphine on track for late 2014 or early 2015 NDA filing by partner Endo Pharmaceuticals RALEIGH, N.C., Aug. 12, 2014 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that along with its commercial partner, Endo Pharmaceuticals, engaged in a positive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding BEMA Buprenorphine for the management of pain severe enough to require daily, around-the-clock,...

2014-08-11 16:28:15

SARASOTA, Fla., Aug. 11, 2014 /PRNewswire/ -- Rock Creek Pharmaceuticals, Inc., (NASDAQ: RCPI), a drug development company focused on chronic inflammatory disease and neurologic disorders, announced today that it filed with the Securities Exchange Commission its Form 10-Q for the second quarter ended June 30, 2014. The company has also announced a clinical and regulatory update. http://photos.prnewswire.com/prnvar/20140811/135143 Second Quarter, 2014: For the three months ended...


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
mallemaroking
  • Nautical, the visiting and carousing of sailors in the Greenland ships.
This word is apparently from a confusion of two similar Dutch words: 'mallemerok,' a foolish woman, and 'mallemok,' a name for some persons among the crew of a whaling vessel.