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Latest Food and Drug Administration Stories

2014-07-30 08:32:52

ENGLEWOOD, Colo., July 30, 2014 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced a positive written response from the FDA in regards to the company's plans to begin production of Ampion(TM) in our new drug manufacturing facility. http://photos.prnewswire.com/prnvar/20120516/MM09116LOGO Dr. Vaughan Clift, Ampio's Chief Regulatory Officer explained, "Satisfying the Chemistry, Manufacturing and Controls (CMC) requirements of a Biological License Application...

smartphone health apps
2014-07-30 03:00:33

SMU Dedman School of Law Download .PDF of full article: Regulation of Mobile Health Technologies Smart phones and mobile devices are on the cusp of revolutionizing health care, armed with mobile health (“mHealth”) apps capable of providing everything from cardiac measurements to sonograms. While tremendous potential exists to broaden access to medical treatment and control costs, several health law experts say in a just-published New England Journal of Medicine (NEJM) report that...

2014-07-29 23:13:58

It’s time for the 9th Annual FDA Inspections Summit, focusing on inspectional readiness. With twin tracks for drug/biologics and device manufacturers, attendees will discover sessions and panels for every FDA-regulated company. Falls Church, VA (PRWEB) July 29, 2014 9th Annual FDA Inspections Summit **Presented by FDAnews** Oct. 22-24, 2014 – Bethesda, MD http://www.fdanews.com/InspectionsSummit2014 What’s the state of FDA’s Quality Metrics Initiative? When will drug and...

2014-07-29 23:13:31

On July 25, the FDA informed that GE Healthcare Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC) are recalled because they may fail or provide incorrect CO2 values. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) July 29, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from...

2014-07-29 23:00:51

The installation and use of non-clinically regulated Nurse Call Life Safety Systems across Australian healthcare facilities is of growing concern. Perth WA, Australia (PRWEB) July 30, 2014 Recent international changes to the definition and regulation of medical devices have determined Nurse Call Systems to be considered medical devices. Under Australian and international legislation, this requires all Nurse Call Systems to be clinically regulated, audited and certified. This regulatory...

2014-07-29 08:32:38

Recent U.S. FDA 510(K) Clearance and Appointment of New CEO Create Optimal Growth Environment for Company WHEAT RIDGE, Colo., July 29, 2014 /PRNewswire/ -- The BioFusionary Corporation, Inc. (TBC), a medical technology company focused on developing a proprietary electromagnetic induction platform with aesthetic and surgical applications, today announced it entered into an agreement under which TBC will merge with Australia-based Continuation Investments Limited (COT) in an all-stock...

2014-07-29 08:32:31

HAYWARD, Calif., July 29, 2014 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) performed a general GMP inspection and a Pre-Approval Inspection (PAI) for RYTARY(TM )at the Company's Taiwan manufacturing facility from July 21 to July 26, 2014. At the conclusion of the inspection, the FDA issued a Form 483 with ten inspectional observations. The Taiwan facility was approved for product manufacturing by the FDA in...

2014-07-29 08:32:30

BELLEVILLE, ON, July 29, 2014 /PRNewswire/ - Bioniche Life Sciences Inc. (TSX: BNC) today announced the submission to the US Food and Drug Administration (FDA) Office of Orphan Products Development, an application for Orphan Drug Designation for its Mycobacterial Cell Wall-Nucleic Acid Complex (MCNA) sterile suspension for the treatment of patients with Bacillus Calmette-Guérin (BCG) refractory/relapsing high grade non-muscle invasive bladder cancer. The decision to proceed...

2014-07-29 08:32:10

-- 2014 Nomination follows Previous Nomination in 2013 -- WOODCLIFF LAKE, N.J. and SAN DIEGO, July 29, 2014 /PRNewswire/ -- Eisai Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that BELVIQ(®) (lorcaserin HCl) has been nominated by the Galien Foundation and Awards Committee for the 2014 Prix Galien USA Award in the Best Pharmaceutical Agent category. BELVIQ was previously nominated for this award in 2013. "Eisai's commitment to patient care is the driving force behind our...

2014-07-28 16:26:45

Portugal approves reimbursement for ILUVIEN ATLANTA, July 28, 2014 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that the Norwegian Medicines Evaluation Board has granted marketing authorization to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered...


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
endocarp
  • The hard inner (usually woody) layer of the pericarp of some fruits (as peaches or plums or cherries or olives) that contains the seed.
This word comes from the Greek 'endon,' in, within, plus the Greek 'kardia,' heart.
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