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Latest Food and Drug Administration Stories

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...

2014-07-09 20:22:42

ST. PAUL, Minn., July 9, 2014 /PRNewswire-USNewswire/ -- On Friday, July 11, the second annual nationwide National Gay Blood Drive (NGBD) will take place to raise public awareness and increase pressure on the U.S. Food and Drug Administration (FDA) to change its policy on the long-standing ban on blood donation by men who have had sex with other men (MSM) - a restriction that has been in place since 1983. In Minnesota, the drive is scheduled to occur from 7:30 AM to 4 PM at Memorial Blood...

2014-07-09 16:28:44

BASKING RIDGE, N.J., July 9, 2014 /PRNewswire/ -- Regado Biosciences, Inc., (NASDAQ: RGDO) today announced that, further to their decision to voluntarily pause enrollment in their REGULATE-PCI trial, the United States Food and Drug Administration (FDA) informed the company today that a clinical hold has been placed on all patient enrollment and dosing of either study drug in the ongoing Phase 3 REGULATE-PCI trial. According to the FDA, this action was taken to formalize the...

2014-07-09 16:28:10

Study calls for more focus on long-term outcomes in pediatric trials of drugs intended for chronic use BOSTON, July 9, 2014 /PRNewswire-USNewswire/ -- 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...

2014-07-09 08:27:39

CRANBURY, N.J., July 9, 2014 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE MKT: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application Serial Number 13/910,422 (the '422 application). The application includes...

2014-07-08 23:14:36

On July 2, the FDA announced that Medtronic Duet External Drainage and Monitoring System is recalled (Class I). In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) July 08, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Medtronic Duet External Drainage and Monitoring System. The FDA informed on July 2,...

2014-07-08 23:08:08

Matters Involving Ongoing Litigation to Be Discussed DALLAS (PRWEB) July 08, 2014 Parties involved in lawsuits regarding the anti-psychotic drug Risperdal are scheduled to meet in the Philadelphia Court of Common Pleas to hold a conference to discuss moving litigation forward, the national law firm of Baron and Budd reports. The plaintiffs in the lawsuits accuse Janssen Pharmaceuticals, as well as parent company Johnson & Johnson, of allegedly failing to properly warn users of...


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
tesla
  • The unit of magnetic flux density in the International System of Units, equal to the magnitude of the magnetic field vector necessary to produce a force of one newton on a charge of one coulomb moving perpendicular to the direction of the magnetic field vector with a velocity of one meter per second. It is equivalent to one weber per square meter.
This word is named for Nikola Tesla, the inventor, engineer, and futurist.