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Latest Food and Drug Administration Stories

2014-08-28 23:15:02

Learn how to navigate an advisory panel from an insider’s perspective. FDAnews has teamed Chris Sloan, Principal Consultant at Quintiles Consulting and former FDA device advisory panelist, and Michael Morton, Medtronic’s chief for global regulatory affairs, in a 90-minute presentation on the FDA advisory panel process. Falls Church, VA (PRWEB) August 28, 2014 FDA Device Advisory Panel Review Process: How to Ensure Successful Outcomes **FDAnews Webinar** Sept. 24, 2014 — 1:30 p.m....

2014-08-28 23:07:25

Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that Kristen DeVito, Global Director Clinical Supply Services, and Chris Greco, Manager, Comparator and Ancillary Supplies, will present “Critical Path Sourcing Strategies for Active Control Clinical Trials” at the forthcoming US Clinical Trials Supply Conference, which takes place on the 9th – 10th...

2014-08-28 12:29:56

PITTSBURGH, Aug. 28, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its abbreviated new drug application (ANDA) for a three times per week Glatiramer Acetate Injection 40 mg/mL has been accepted for filing by the U.S. Food and Drug Administration (FDA). This product is the generic version of Teva's Copaxone® 40 mg/mL, which is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS)....

2014-08-28 12:29:50

Ribbon-Cutting Ceremony Scheduled for September 3, 2014 ROCKVILLE, Md., Aug. 28, 2014 /PRNewswire/ -- Tasly Pharmaceuticals, Inc., a global leader in Pharmaceuticals, Biologics, and Nutraceuticals, will hold a ribbon-cutting ceremony on September 3, 2014, in Tasly's corporate offices in Rockville, MD. The ceremony will mark the official launch of Tasly Pharmaceuticals, Inc. as the North American headquarters of Tasly Holding Group, a global technology company established in China...

2014-08-28 12:29:14

MINNEAPOLIS, Aug. 28, 2014 /PRNewswire/ -- Nonin Medical, Inc., the inventor of finger pulse oximetry and a leader in noninvasive medical monitoring, today announced that the Food and Drug Administration (FDA) has cleared the Nonin Model 3231 OEM/eHealth finger pulse oximeter for use in the United States. The finger pulse oximeter plugs into a telemedicine hub or kiosk through a USB connector and measures oxygen saturation and pulse rate in pediatric to adult patients. The Model 3231...

2014-08-28 08:27:37

-- Fujifilm's pAVEway(TM) Platform Demonstrated >25-fold Improvement in SYN-004 Expression Titers -- ROCKVILLE, Md., Aug. 28, 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, and FUJIFILM Diosynth Biotechnologies UK Limited (Fujifilm), announced today confirmation of exceptional results from the initial phase of cGMP manufacturing of...

2014-08-27 23:03:35

New study “Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices (2014 Edition)” developed by Access China Management Consulting is now available MarketPublishers.com. London, UK (PRWEB) August 27, 2014 China’s regulatory framework for medical devices is going through a period of dramatic changes. The country’s new leaders have admitted that the regulations for supervision and administration of medical...

2014-08-27 12:30:03

LYNDHURST N.J. and NINGBO, China, Aug. 27, 2014 /PRNewswire/ -- Amerigen Pharmaceuticals Limited ("Amerigen") and the Ningbo Menovo Pharmaceutical Co., Ltd, ("Menovo") today announced they had entered into a collaboration agreement regarding the development of generic pharmaceuticals, primarily targeting the United States market. Under the terms of the agreement, Amerigen and Menovo will jointly develop products for Amerigen to commercialize in the United States. Menovo will be...

2014-08-27 08:28:22

THOUSAND OAKS, Calif., Aug. 27, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the U.S. Food and Drug Administration (FDA) has granted priority review designation for ivabradine for the treatment of chronic heart failure (HF). Ivabradine is an oral drug that inhibits the I(f) current ("funny" current) in the sinoatrial node, the body's cardiac pacemaker.(1) Ivabradine works to slow the heart rate without negative effects on myocardial contractility or ventricular...

2014-08-27 08:27:21

REDWOOD CITY, Calif., Aug. 27, 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 that senior management will be participating at the FBR Healthcare One on One Conference and presenting at the Morgan Stanley Global Healthcare Conference. Details of the two events are as follows: FBR Healthcare One...


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
grass-comber
  • A landsman who is making his first voyage at sea; a novice who enters naval service from rural life.
According to the OED, a grass-comber is also 'a sailor's term for one who has been a farm-labourer.'