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Latest Food and Drug Administration Stories

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...

2014-09-12 23:00:22

Testosterone Lawsuit Claims Continue As The FDA Seeks Answers From Its Advisory Panel Over Cardiovascular Risks Associated With Testosterone Replacement Therapy. Columbus, OH (PRWEB) September 13, 2014 As low testosterone lawsuit claims continue to increase, Wright & Schulte LLC notes two of the U.S. Food & Drug Administration (FDA) advisory committees will meet on September 17 and 18 to discuss controversial public health issues surrounding testosterone replacement therapy. The...

2014-09-12 16:23:58

NEW YORK, Sept. 12, 2014 /PRNewswire/ -- Pomerantz LLP has filed a class action lawsuit against Impax Laboratories, Inc. ("Impax" or the "Company")(NASDAQ: IPXL) and certain of its officers. The class action, filed in United States District Court, District of New Jersey, and docketed under 14-cv-03673, is on behalf of a class consisting of all persons or entities who purchased Impax securities between May 20, 2013 and July 28, 2014, inclusive (the "Class Period"). This class action...

2014-09-12 12:25:50

-- Company Expects to File IND to Support Clinical Trials in Mid-2015 -- ROCKVILLE, Md., Sept. 12, 2014 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a biotechnology company developing novel anti-infective biologic and drug programs targeting specific pathogens that cause serious infections and diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to the Company's proprietary SYN-005 monoclonal antibody (mAb)...

2014-09-12 12:25:25

FALLS CHURCH, Va., Sept. 12, 2014 /PRNewswire-iReach/ -- 9(th) Annual FDA Inspections Summit **Presented by FDAnews** Oct. 22-24, 2014 - Bethesda, MD Early Bird Registration discount ends on Friday, Sept. 19. http://www.fdanews.com/9thInspectionsSummitEarlyBird Photo - http://photos.prnewswire.com/prnh/20140912/145652 What better way to prepare for the next inspection than to get a glimpse into the inner workings of an investigator's mindset before, during and after an inspection. Come to...

2014-09-12 08:25:44

SARASOTA, Fla., Sept. 12, 2014 /PRNewswire/ -- Rock Creek Pharmaceuticals, Inc., (NASDAQ: RCPI), a drug development company focused on chronic inflammatory disease and neurologic disorders, announced today it has received a written response from the U.S. Food and Drug Administration (FDA) in response to the New Dietary Ingredient Notification (NDIN) for the formulations of Anatabloc® and CigRx® submitted by the Company in June 2014. The letter indicated that the FDA considers...

2014-09-12 08:25:15

Accomplished regulatory leader to advance Epic's circulating tumor cell (CTC) technology for 510(k) and PMA approvals SAN DIEGO, Sept. 12, 2014 /PRNewswire/ -- Epic Sciences announced today the appointment of Glen Paul Freiberg, RAC as vice president of regulatory affairs and quality assurance. Mr. Freiberg has more than 35 years of FDA-related experience and is recognized as a key leader in successful regulatory and compliance strategies for diagnostic products. Epic's circulating...

2014-09-11 23:12:12

All manufacturers of combination products need to conduct a comprehensive gap analysis and determine where to make changes to their manufacturing operations, SOPs, training programs and quality assurance. Mark the calendar for Wednesday, Oct. 1, for On-Demand access to Suzanne O’Shea’s immensely popular webinar on combination products. Falls Church, VA (PRWEB) September 11, 2014 All manufacturers of combination products need to conduct a comprehensive gap analysis and determine where...

2014-09-11 23:11:35

Three companies—one European, two American—have teamed up to enable European manufacturers of implantable ophthalmic devices to comply with anticipated regulatory demands for ongoing post-market outcomes data. ZURICH, MADISON, WI, and NEW YORK (PRWEB) September 11, 2014 Three companies—one European, two American—have teamed up to enable European manufacturers of implantable ophthalmic devices to comply with anticipated regulatory demands for ongoing post-market outcomes data. In...


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.'