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Latest Food and Drug Administration Stories

2014-10-10 12:24:40

RALEIGH, N.C., Oct. 10, 2014 /PRNewswire/ -- BioDelivery Sciences International, Inc. (BDSI) (NASDAQ: BDSI) announced that J. Chris Prue, RPh, MBA has joined BDSI as Vice President of Regulatory Affairs and Quality Assurance. Mr. Prue brings more than 30 years of pharmaceutical industry experience in regulatory affairs and quality assurance to BDSI. He has held positions of increasing responsibility at The Upjohn Company, Glaxo Inc., GlaxoWellcome and Purdue Pharma LP. Recently...

2014-10-10 08:24:17

CUPERTINO, Calif., Oct. 10, 2014 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced that data for POSIDUR((TM)) (SABER(®)-Bupivacaine), an investigational drug for administration into the surgical site to produce post-surgical analgesia, is being presented at ANESTHESIOLOGY((TM)) 2014, the annual meeting of the American Society of Anesthesiologists (ASA). The meeting will be held October 11-15, 2014 at the Ernest N. Morial Convention Center in New Orleans....

2014-10-09 23:12:24

Following an FDA consumer update on blood pressure kiosk accuracy, national experts recognize PharmaSmart as the only kiosk that “can be recommended by physicians for their patients”. The published expert recommendation is a first for any blood pressure kiosk. Rochester, NY (PRWEB) October 09, 2014 National leaders in hypertension have acknowledged PharmaSmart as the only blood pressure kiosk solution that can be “recommended by physicians” for patient monitoring. The...

2014-10-09 23:12:03

On October 6, the FDA announced that three lots of Ketorolac Tromethamine Injection, USP, 30mg/mL single-dose vials, distributed by Sagent, are recalled due to incorrect labeling. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) October 09, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Ketorolac...

2014-10-09 23:06:16

Provectus Biopharmaceuticals Collaborates with ERT’s COA Experts to Understand Patient Perspective during Melanoma Drug Development PHILADELPHIA, PA (PRWEB) October 09, 2014 ERT, a leading global solution provider for high-quality patient safety and efficacy endpoint data collection, today announced that Provectus Biopharmaceuticals (NYSE MKT: PVCT) is collaborating with ERT’s Clinical Outcome Assessment (COA) consultants on their Phase III trial of agent PV-10 for intralesional (IL)...

2014-10-09 23:03:44

Eli Lilly failed to warn that the testosterone replacement drug, Axiron, may increase the risk of heart attack and stroke, a lawsuit filed in federal court alleges. Parker Waichman LLP notes that there have been safety concerns regarding testosterone therapy following reports that they may carry cardiovascular risks. Port Washington, New York (PRWEB) October 09, 2014 Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs and...

2014-10-09 08:28:26

Despite Favorable Clinical Evidence, Price Competition Will Limit Market Growth Somewhat, According to Findings from Decision Resources Group BURLINGTON, Mass., Oct. 9, 2014 /PRNewswire/ -- Decision Resources Group finds that the markets for gastrointestinal (GI) endoscopy devices in the United States and Europe will expand to reach values of $3.5 billion and $1.6 billion, respectively, by 2023. Though both markets will be negatively impacted by price competition as a result of group...

2014-10-09 08:27:53

CEO to Discuss Milestone FDA Approval of ILUVIEN as the First Long-Term Treatment for Diabetic Macular Edema ATLANTA, Oct. 9, 2014 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, announced today that it will present at the Ophthalmology Innovation Summit (OIS) at the American Academy of Ophthalmology (AAO) annual meeting in Chicago,...

2014-10-09 08:27:21

SAN DIEGO, Oct. 9, 2014 /PRNewswire/ -- Astute Medical, Inc. and CRG today announced that Astute recently achieved a milestone under the terms of its existing term loan agreement with CRG. Under the term loan agreement, CRG will provide up to $30 million to support the commercialization of the NephroCheck(®) Test System. An additional $10 million will become available to Astute upon the achievement of certain revenue milestones. Last month, Astute announced receipt of 510(k)...

2014-10-09 08:27:14

NASDAQ: NVCNTSX: NVC VANCOUVER, Oct. 9, 2014 /PRNewswire/ - Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ: NVCN) (TSX: NVC) today announced that it has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate the U.S. arm of its TIARA-I Early Feasibility Trial for the Company's Tiara(TM) transcatheter mitral valve. The TIARA-I Early Feasibility Trial is a multinational, multicenter trial being conducted to...


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
bellycheer
  • Good cheer; viands.
  • To revel; to feast.
The word 'bellycheer' may come from 'belle cheer', "good cheer".
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