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Latest Food and Drug Administration Stories

2014-07-18 20:21:41

TEMPLE, Texas, July 18, 2014 /PRNewswire/ -- Unique Pharmaceuticals, Ltd., ("Unique" or "the Company") today announced a voluntary nationwide recall of all sterile drug preparations compounded by the outsourcing facility that have not reached the expiration date listed on the products. Unique is initiating the recall due to FDA's concerns associated with Unique's compounding facilities and compounding processes that FDA contends present a lack of sterility assurance and were observed during...

2014-07-18 08:24:51

BELLEVILLE, ON, July 18, 2014 /PRNewswire/ - Bioniche Life Sciences Inc. (TSX: BNC) today provided a key regulatory update on its flagship Phase 3 program, Mycobacterial Cell Wall-Nucleic Acid Complex (MCNA) sterile suspension for the treatment of patients with Bacillus Calmette-Guérin (BCG) refractory high grade non-muscle invasive bladder cancer. MCNA U.S. Regulatory Update Following several months of active dialogue with the U.S. Food and Drug Administration (FDA),...

2014-07-17 23:10:22

On July 1, Oriya Organics LLC announced the recall of Oriya Organics Superfood Protein Medley which contain Organic Sprouted Chia Seed Powder due to possible Salmonella contamination. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) July 17, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Superfood...

2014-07-17 23:05:29

Required Change Reflects Reports of Additional Clotting Not Related to Condition Covered by Current Warnings DALLAS (PRWEB) July 17, 2014 The U.S. Food & Drug Administration (FDA) has ordered testosterone therapy drug makers to provide additional warnings in regard to blood clots to those already in place, the national law firm of Baron and Budd reports. This development occurs as federal litigation involving testosterone treatment lawsuits proceed in the U.S. District Court, Northern...

2014-07-17 12:30:54

BRISBANE, Calif., July 17, 2014 /PRNewswire/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that pirfenidone has been granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). This designation is reserved for drugs that are intended to treat a serious or life threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant...

2014-07-17 08:28:43

PITTSBURGH, July 17, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that the U.S. District Court for the District of New Jersey granted its motion for a permanent injunction against GlaxoSmithKline (GSK) in relation to Paroxetine CR, the generic version of GSK's Paxil(®) CR. GSK is now precluded from supplying product to Apotex, which marketed the product as an authorized generic. Mylan had previously been awarded damages in the amount of $106,700,000 by the District...

2014-07-17 08:28:41

SANTA ROSA, Calif., July 17, 2014 /PRNewswire/ -- Ruthigen, Inc., (NASDAQ: RTGN) today announced that it has treated the first human subjects with its leading drug candidate RUT58-60 in a 30 patient, 21-day skin irritation trial, which is expected to be completed in August 2014. In June 2014, Ruthigen's Investigational New Drug (IND) application became effective following review by the U.S. Food and Drug Administration (FDA). Ruthigen is developing RUT58-60 as a safe and fast...

2014-07-16 23:10:51

Dr. Ginette Collazo, a 15 year veteran of helping drug, biologic and device firms reduce manufacturing errors by 50 percent or more, will conduct a one-of-a-kind workshop that teaches quality managers and manufacturing excellence professionals how to reduce errors and improve quality metrics. Based on her ground-breaking research, Dr. Collazo explains how small improvements in both manufacturing systems and improved employee training can deliver big results. Falls Church, VA (PRWEB) July...

2014-07-16 23:10:07

On July 11, the FDA informed consumers on the recall of all White & Blue Lion Inc. Tattoo Ink, Needles and Kits due to microbial contamination. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) July 16, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Tattoo Ink, Needles and Kits. The FDA informed...

2014-07-16 23:04:33

A Food and Drug Administration advisory panel recently met to assess the safety of a device used during hysterectomies and other uterine surgeries. In the wake of that meeting, the defective medical device lawyers of Levy Baldante encourage the FDA to take steps to protect citizens. Philadelphia, PA (PRWEB) July 16, 2014 The law firm of Levy, Baldante, Finney, Rubenstein, Cohen & Chizmar, P.C. recognizes the deep-seated concerns shared by many in regard to laparoscopic power...


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
jument
  • A beast of burden; also, a beast in general.
'Jument' ultimately comes from the Latin 'jugum,' yoke.
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