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Latest Food and Drug Administration Stories

2014-07-11 16:23:31

DUBLIN, July 11, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-release tablets, 10 mg/10 mg. Actavis' ANDA product is a generic version of Duchesnay Inc.'s Diclegis(®), which is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to...

2014-07-11 08:24:57

SYDNEY and BEDMINSTER, N.J., July 11, 2014 /PRNewswire/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) today provided feedback on its 9 July End-of-Review (EOR) meeting with the United States Food and Drug Administration (FDA). The meeting was held to discuss the feasibility and requirements for approving Moxduo, an immediate release Dual Opioid(®), for the treatment of moderate to severe acute pain. In advance of the meeting, QRxPharma outlined several questions to discuss with...

2014-07-10 23:13:03

On July 9, the FDA notified consumers not to purchase or use certain weight loss products including Mix Fruit Slimming, Lingzhi Cleansed Slim Tea, 24 Ince, Lipo 8 Burn Slim Capsules, Sliming (sic) Diet By Pretty White, and Trim-Fast Slimming Softgel. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) July 10, 2014 AttorneyOne.com, a recognized authority on law, update the website daily...

2014-07-10 23:07:22

Activist/filmmaker organizing National Gay Blood Drive on July 11 to show impact of changing donor ban for millions of Americans. Nationwide, United States of America (PRWEB) July 10, 2014 Since 1983, the U.S. Food and Drug Administration (FDA) has banned gay and bisexual men from donating blood. Men who have had sexual contact with men (MSM donors) are deferred by the FDA for life, and every blood bank in the U.S. is mandated to comply with this policy. Every two seconds someone in the...

2014-07-10 23:02:22

The Firm is investigating morcellator lawsuits on behalf of women who allegedly experienced the spread of uterine cancers due to the use of a power morcellator in gynecological surgery. New York, New York (PRWEB) July 10, 2014 As hysterectomy cancer lawsuits (http://www.gynecaremorcellatorlawsuit.com/) against the manufacturers of power morcellators continue to mount in U.S. courts, Bernstein Liebhard LLP notes that a panel of advisors to the U.S. Food & Drug Administration (FDA) is...

2014-07-10 10:28:40

Boston Children's Hospital Study calls for more focus on long-term outcomes in pediatric trials of drugs intended for chronic use Over the last 60 years, the U.S. Food and Drug Administration (FDA) approved 20 medications for attention deficit/hyperactivity disorder (ADHD) based on clinical trials that were not designed to study their long-term efficacy and safety or to detect rare adverse events, researchers at Boston Children's Hospital report today in PLOS ONE. The study highlights...

2014-07-10 08:27:41

SHENZHEN, China, July 10, 2014 /PRNewswire/ -- Beike Biotechnology Co., Ltd. (Beike) has officially been accepted into the approval process for the Chinese Food and Drug Administration for the use of human umbilical cord (UC) derived mesenchymal stem cells (MSCs) for clinical translation and treatment of Systemic Lupus Erythamatosus (SLE). After a recent clinical study was published showing Beike's mesenchymal stem cells effective in treating SLE...

2014-07-09 23:08:49

Innovation Breakdown, a new book by Joseph V. Gulfo, details a broken system and how even the smallest changes can speed up the time to market for medical innovations that save lives. New York, NY (PRWEB) July 09, 2014 Joseph V. Gulfo​, MD MBA​ has successfully brought three medical innovations through the FDA over the course of his 25 year career. But the third time became a decade-long struggle of Herculean proportions, that included an​ unlawful ​withholding of approval by the...

2014-07-09 23:04:27

Kristine Kraft, partner at Schlichter, Bogard & Denton, LLP, notes that Xarelto® is surpassing Pradaxa® in the number of reported adverse events, according to the Institute for Safe Medication Practices’ most recent Quarter Watch Report. The attorneys at Schlichter, Bogard & Denton, LLP are offering free and confidential case reviews to those who allege to have suffered serious bleeding events after using Xarelto®. St. Louis, MO (PRWEB) July 09, 2014 According to...

2014-07-09 23:02:41

The Firm is evaluating hysterectomy cancer lawsuits on behalf of women who experienced the spread of uterine sarcoma and other cancers, allegedly due to the use of power morcellators in laparoscopic hysterectomies and fibroid removals. New York, New York (PRWEB) July 09, 2014 As the Firm continues to evaluate morcellator lawsuits (http://www.gynecaremorcellatorlawsuit.com/) on behalf of women who allegedly experienced the spread of uterine cancers due to the use of power morcellators 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
siliqua
  • A Roman unit of weight, 1⁄1728 of a pound.
  • A weight of four grains used in weighing gold and precious stones; a carat.
  • In anatomy, a formation suggesting a husk or pod.
  • The lowest unit in the Roman coinage, the twenty-fourth part of a solidus.
  • A coin of base silver of the Gothic and Lombard kings of Italy.
'Siliqua' comes from a Latin word meaning 'a pod.'
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