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Latest Food and Drug Administration Stories

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...

2014-10-09 04:20:56

PHILADELPHIA, October 9, 2014 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that it has received further guidance from the U.S. Food and Drug Administration (FDA) on the regulatory path for SHP 465 (triple-bead mixed amphetamine salts MAS), an investigational oral stimulant medication being evaluated as a potential treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) in adults. On April 25, 2014, in written correspondence, the FDA responded to...

2014-10-08 16:27:08

DUBLIN, October 8, 2014 /PRNewswire/ -- Research and Markets ( http://www.researchandmarkets.com/research/m9tbs3/us_orphan_drug) have announced the addition of the "US Orphan Drug Clinical Pipeline Insight 2014" [http://www.researchandmarkets.com/research/m9tbs3/us_orphan_drug ] report to their offering. (Logo: http://photos.prnewswire.com/prnh/20130307/600769 ) Rare diseases are also known as Orphan diseases. These diseases are generally categorized as chronic,...

2014-10-08 08:27:59

New Device Featured at the European Academy of Dermatology and Venereology* WAYLAND, Massachusetts, October 8, 2014 /PRNewswire/ -- Syneron Medical Ltd. (NASDAQ:ELOS), a leading global aesthetic device company, announced today the international launch of the new PicoWay(TM) picosecond device at the 23rd European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam, The Netherlands, October 8-12, 2014. PicoWay is a state-of-the-art dual wavelength device, with...

2014-10-08 08:26:46

SAN DIEGO, Oct. 8, 2014 /PRNewswire/ -- Suneva Medical, Inc., a privately-held aesthetics company, today announced the appointment of Peter Barton Hutt as a member of its Board of Directors. Known in the legal community as the "dean of the food and drug bar," Mr. Hutt has been a leading food and drug law practitioner and scholar for half a century. Mr. Hutt has specialized in food and drug law at the Washington D.C. firm of Covington and Burling since 1960, pausing only to serve as...

2014-10-07 12:32:27

Speakers include Chimerix President and CEO M. Michelle Berrey, M.D., M.P.H. and Noted Ethicist Arthur L. Caplan, Ph.D. PRINCETON, N.J., Oct. 7, 2014 /PRNewswire/ -- WIRB-Copernicus Group (WCG), the world's largest provider of regulatory and ethical review services and software to support clinical research, announced that it will be hosting a webinar entitled, "Early Access to Investigational Drugs: Lessons from Ebola," at 3:00 p.m. EDT today....

2014-10-07 08:30:22

MILFORD, Pa., Oct. 7, 2014 /PRNewswire/ -- Manzo Pharmaceuticals, Inc. (OTCPink:FOGCD), today announced that after discussions with the Food and Drug Administration, it has been determined that its long lasting lactose digestive aid, Lacto-Freedom(TM), will not need FDA approval to be released to the public. The FDA considers the probiotic to be a dietary "supplement", and therefore outside the scope of a very long and expensive FDA approval process that would be required if the...


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
negawatt
  • A unit of saved energy.
Coined by Amory Lovins, chairman of the Rocky Mountain Institute as a contraction of negative watt on the model of similar compounds like megawatt.