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Latest Food and Drug Administration Stories

2014-09-16 23:03:11

Topical research report “Pediatric Drug Development - Regulatory Challenges and Commercial Opportunities” worked out by CBR Pharma Insights is now available at MarketPublishers.com. London, UK (PRWEB) September 16, 2014 Since the adoption of pediatric legislation, the number of paediatric clinical trials has risen considerably in line with increased investment in R&D for pediatric drugs. In the USA, over 350 product labels include novel paediatric information and more than 130...

2014-09-16 20:27:17

-- Survey Data Requested by FDA for the September 26 Patient-Focused Drug Development Meeting for Idiopathic Pulmonary Fibrosis CHICAGO, Sept. 16, 2014 /PRNewswire-USNewswire/ -- The Pulmonary Fibrosis Foundation (PFF) announced today that it has submitted survey data from more than 1,100 patients and families suffering from pulmonary fibrosis (PF) to the U.S. Food and Drug Administration (FDA) for the Patient-Focused Drug Development Meeting for Idiopathic Pulmonary Fibrosis on...

2014-09-16 12:36:52

WINNETKA, Calif., Sept. 16, 2014 /PRNewswire/ -- Green Cures & Botanical Distribution Inc. (OTC Pink: GRCU) ("Green Cures") announced today that Allcbd.com, the newest member of Green Cures' portfolio of websites, is now receiving and processing orders from customers across the United States. Additionally, Green Cures is pleased to announce that Allbotanical.com is now shipping orders internationally. Subsequently, the company announced the immediate availability of South African-...

2014-09-16 08:30:17

Innovative needle design to enhance patient safety LAWRENCE, Mass., Sept. 16, 2014 /PRNewswire/ -- NxStage® Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today announced its single needle technology, OneSite(TM), has received FDA clearance. http://photos.prnewswire.com/prnvar/20110503/MM94799LOGO The OneSite employs a unique dual lumen needle design offered in both a sharp version with MasterGuard® and a buttonhole version with SteriPick®...

2014-09-15 23:10:01

On September 9, the FDA announced that it requested the recall of sterile drug products by Downing Labs (aka NuVision Pharmacy) due to lack of sterility. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) September 15, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on sterile drug products. Following a...

2014-09-15 23:03:17

ComplianceOnline, the leading GRC advisory network, and regulatory affairs expert, Dr. Mukesh Kumar will conduct a two day seminar on requirements of SOPs for FDA-regulated industries. Durham, North Carolina (PRWEB) September 15, 2014 ComplianceOnline, the leading governance, risk and compliance advisory network with over 500 experts in various regulatory subjects, today announced a seminar on SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations. The two day...

2014-09-15 08:29:28

Company CEO to present on September 17, 2014 JERUSALEM, September 15, 2014 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (http://www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today the Company's CEO, Nadav Kidron will present at DC Finance's Family Office & Wealth Management Annual Conference. Presentation Details: DC Finance's East Coast Family Office & Wealth...

2014-09-15 08:28:36

MONMOUTH JUNCTION, N.J., Sept. 15, 2014 /PRNewswire/ -- Vernalis plc (LSE: VER) and Tris Pharma, Inc. ("Tris") are pleased to announce that the U.S. Food and Drug Administration ("FDA") has confirmed that the New Drug Application ("NDA") for Tuzistra(TM) XR ("CCP-01") has been accepted for full review. This triggers a milestone payment from Vernalis to Tris. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for conclusion of its review of 30 April 2015. Under...

2014-09-15 08:28:17

PITTSBURGH and HYDERABAD, India, Sept. 15, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Laboratories Limited has entered into an agreement with Gilead Sciences, Inc. under which Mylan has been licensed the non-exclusive rights to manufacture and distribute sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir in 91 developing countries. Sofosbuvir is marketed by Gilead under the brand name Sovaldi®....

2014-09-13 23:01:51

The Firm is evaluating legal claims on behalf of men who suffered heart attacks, strokes, blood clots and other cardiovascular side effects, allegedly due to their use of testosterone replacement drugs. New York, New York (PRWEB) September 13, 2014 As testosterone lawsuit (http://www.drugbot.com/testosterone/lawsuit/) filings continue to mount in U.S. courts, Bernstein Liebhard LLP notes that the U.S. Food & Drug Administration (FDA) will convene a meeting of outside advisors on...


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.'