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Latest Food and Drug Administration Stories

2014-10-17 08:25:39

BEIJING, Oct. 17, 2014 /PRNewswire/ -- China Biologic Products, Inc. (NASDAQ: CBPO, "China Biologic" or the "Company"), a leading fully integrated plasma-based biopharmaceutical company in China, today announced that the Company has received approval from the China Food and Drug Administration (the "CFDA") for commercial manufacturing of human prothrombin complex concentrate ("PCC") at its Shandong Taibang facility. The CFDA inspected Shandong Taibang's new coagulation factor...

2014-10-16 23:12:37

On October 10, the FDA announced that the ICU Medical ConMed Stat2 Flow Controller is recalled because it was assembled with the wrong internal component. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) October 16, 2014 AttorneyOne.com, a recognized authority on law, updates the website daily regarding all the latest information from the FDA on Stat2 Flow Controller. The FDA...

2014-10-16 23:06:33

According to new report from BCC Research, the global market for nanoparticles in biotechnology and pharmaceuticals is expected to reach $79.8 billion in 2019, with a compound annual growth rate (CAGR) of 22% for the period 2014 to 2019. (PRWEB) October 16, 2014 BCC Research (http://www.bccresearch.com) reveals in its new report, NANOPARTICLES IN BIOTECHNOLOGY, DRUG DEVELOPMENT AND DRUG DELIVERY, the global market for nanoparticles in biotechnology and pharmaceuticals is expected to...

2014-10-16 23:03:55

One UDI deadline has come and gone and other deadlines loom in the coming months. Come to Chicago on Nov. 11 or Boston on Nov. 13 for a crash course in UDI, taught by a seasoned expert in medical device and diagnostics compliance issues. Falls Church, VA (PRWEB) October 16, 2014 UDI: It Won’t Wait Until You Are Ready **Presented by FDAnews and Ombu Enterprises** Nov. 11, 2014 – Chicago, IL Nov. 13, 2014 – Waltham, MA http:// http://www.fdanews.com/UDI1DayWorkshop One Unique Device...

2014-10-16 12:30:21

First FDA Approved Treatments in United States for Devastating Lung Disease Affecting More than 200,000 Americans, with Survival Rate of Just Three to Five Years CHICAGO, Oct. 16, 2014 /PRNewswire-USNewswire/ -- The Pulmonary Fibrosis Foundation (PFF) applauds the approval of Esbriet(®) (pirfenidone) and OFEV(®) (nintedanib) by the U.S. Food and Drug Administration (FDA) as the first disease-specific therapies for idiopathic pulmonary fibrosis (IPF) in the United States....

2014-10-16 08:31:22

DUBLIN, Oct. 16, 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 Methylphenidate Hydrochloride for Extended-release Oral Suspension, 5 mg/mL. Actavis' ANDA product is a generic version of Pfizer and Tris Pharma's Quillivant XR(®), which is a central nervous system stimulant indicated for the treatment of Attention Deficit...

2014-10-16 08:30:28

ST. LOUIS, Oct. 16, 2014 /PRNewswire/ -- BioReliance(®) (www.bioreliance.com), Sigma-Aldrich Corporation's (NASDAQ: SIAL) biologics and early-development services business under SAFC(®) Commercial (www.sigmaaldrich.com/safc), has introduced select in vitro ADME (absorption, distribution, metabolism and excretion) and toxicology testing services for pharmaceutical, chemical and industrial consumer products to its service offering. The broad set of highly predictive assays use a novel...

2014-10-15 23:11:30

On October 10, the FDA announced that several lots of CareFusion 203, EnVe and ReVel ventilators are recalled due to power connection failure. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) October 15, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on EnVe and ReVel ventilators. The US FDA announced on...

2014-10-15 23:02:20

The Firm is evaluating potential morcellator lawsuits on behalf of women who allegedly experienced the spread of uterine sarcoma and other cancers due to the use of power morcellators in laparoscopic hysterectomy and fibroid removal. New York, NY (PRWEB) October 15, 2014 Federal health regulators investigating the potential link between the use of power morcellators (http://www.injurybeacon.com/power-morcellator/) and the spread of undiagnosed uterine sarcoma and other cancers are not...

2014-10-15 23:01:54

mediStat Specialized Pharmacy today announced it has voluntarily registered with the US Food and Drug Administration (FDA) as a Human Drug Compounding Outsourcing Facility under section 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act. Foley, AL (PRWEB) October 15, 2014 mediStat Specialized Pharmacy today announced it has voluntarily registered with the US Food and Drug Administration (FDA) as a Human Drug Compounding Outsourcing Facility under section 503B of the Federal Food,...


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
maffling
  • To stammer.
  • Present participle of maffle, to stammer.
  • A simpleton.
The word 'maffle' may come from a Dutch word meaning 'to move the jaws' or a French word meaning 'having large cheeks'.