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Latest Food and Drug Administration Stories

2014-08-31 23:03:49

Datex Pharmaceutical Software now includes a suite of features which enables compliance of the new FDA regulation, the Drug Quality Security Act (DQSA). Clearwater FL (PRWEB) August 31, 2014 Datex Pharmaceutical Software now includes a suite of features which enables compliance of the new FDA regulation, the Drug Quality Security Act (DQSA). The FDA Drug Quality and Security Act (DQSA) was signed into law in late 2013. Established to address threats to patient safety and security, the...

2014-08-29 23:10:24

Award Includes Operations and Maintenance in Support of CFSAN Reston, VA (PRWEB) August 29, 2014 The Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), awarded a five-year, single-award, indefinite delivery, indefinite quantity (IDIQ) contract and the first two task orders: “FARM V Operations and Maintenance” and “Development, Modernization and Enhancement (DME) for FARM VI” to the team of...

2014-08-29 23:09:31

On August 26, the FDA announced the recall of several sterile convenience surgical packs, by Customed Inc., due to possible loss 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) August 29, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on sterile convenience surgical packs. The US FDA...

2014-08-29 20:21:53

NEW YORK, Aug. 29, 2014 /PRNewswire/ -- Pomerantz LLP has filed a class action lawsuit against EDAP TMS S.A. ("EDAP" or the "Company") (NASDAQ: EDAP) and certain of its officers. The class action, filed in United States District Court, Southern District of New York, and docketed under 14-cv-6069, is on behalf of a class consisting of all persons or entities who purchased EDAP securities between February 1, 2013 and July 30, 2014, inclusive (the "Class Period"). This class action...

2014-08-29 16:24:04

-- Clinical and preclinical programs remain on track SAN DIEGO, Aug. 29, 2014 /PRNewswire/ -- Mast Therapeutics, Inc. (NYSE MKT: MSTX), an emerging biopharmaceutical company, announced today that Santosh Vetticaden, Chief Medical Officer and Senior Vice President, will be leaving the Company, for personal reasons, in mid-September. Edwin L. Parsley, D.O., the Chief Medical Officer of Aires Pharmaceuticals, which Mast acquired earlier this year, will assume Dr. Vetticaden's former...

2014-08-28 23:15:55

For 30 years, devicemakers have relied on The GMP Letter for the latest on the FDA's interpretation and enforcement of cGMPs and Quality Systems Regulation, information readers need to stay in compliance. Each monthly issue brings its readers updates on the FDA’s approach to facility inspections, changes to the EU’s unannounced inspections and the latest on joint inspections in these and other jurisdictions. Falls Church, VA (PRWEB) August 28, 2014 Subscribe to The GMP Letter...

2014-08-28 23:15:08

On August 1, New England Greens, LLC dba Vibrant Health announced that specific lots of Green Vibrance and one lot of Rainbow Vibrance are recalled because of possible health risk. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) August 28, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Green Vibrance...

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)....


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
tessitura
  • The prevailing range of a vocal or instrumental part, within which most of the tones lie.
This word is Italian in origin and comes from the Latin 'textura,' web, structure.