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Latest Food and Drug Administration Stories

2014-09-18 23:13:39

Xarelto® drug takers allege adverse medical events, such as uncontrolled bleeding and wrongful deaths, occurred after taking the blood clot prevention drug. Glen Lerner Injury Attorneys announce they now offer free class action claim reviews against drug manufacturers from those who believe they were injured after taking the drug and not properly warned about the increased potential for serious and irreversible bleeding risks due to lack of reversal agent. U.S.A. (PRWEB) September 18,...

2014-09-18 23:11:47

On September 15, Gel Spice Company, Inc. announced the recall of 16,443 cases of Fresh Finds Ground Black Pepper due to possible Salmonella risk. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) September 18, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Ground Black Pepper. Gel Spice Company, Inc....

2014-09-18 20:23:09

SOUTHLAKE, Texas, Sept. 18, 2014 /PRNewswire/ -- Low T Center endorses the recommendations of the joint FDA committee meeting in Hyattsville, Maryland earlier this week. The FDA convened the meeting to assess the proper patient population for testosterone therapy (TRT), as well as to assess potential cardiovascular risk associated with TRT. Examining recent claims from studies that TRT affects cardiovascular health, the committee found that "available epidemiological studies do not...

2014-09-18 08:28:59

- Spectrum receives a 19.99% stake (pre-transaction) in CASI, a NASDAQ-listed, oncology-focused Company with expertise and focus on markets in China and a $1.5 million promissory note HENDERSON, Nev. and ROCKVILLE, Md., Sept. 18, 2014 /PRNewswire/ -- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, and CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a...

2014-09-17 23:02:33

TRT Litigation Subcommittee, Including Zoll, Kranz & Borgess Attorneys Michelle L. Kranz and James G. O’Brien, Advocates for Stronger Testosterone Warnings Before FDA Committee Toledo, Ohio (PRWEB) September 17, 2014 The Food and Drug Administration (FDA) has scheduled a hearing for today, September 17, 2014, to consider: 1. The appropriate indicated population for Testosterone Replacement Therapy (TRT), and 2. The potential for adverse cardiovascular outcomes associated with...

2014-09-17 20:22:10

OTTAWA, Sept. 17, 2014 /CNW/ - Health Canada has taken the precautionary step of asking IPCA Laboratories in India to voluntarily stop shipment of products to Canada based on a review of a recent good manufacturing practices (GMP) inspection report by the U.S. Food and Drug Administration (FDA) where they identified falsification and manipulation of data issues at the company. IPCA has not disputed the FDA findings with Health Canada. The FDA has not issued a recall of any of the...

2014-09-17 12:27:05

New multi-year grant furthers non-profit organization's work to accelerate the drug development process TUCSON, Ariz., Sept. 17, 2014 /PRNewswire-USNewswire/ -- The Critical Path Institute (C-Path) announced today that the U.S. Food and Drug Administration (FDA) has awarded the organization $2.1 million in first year funding of a five-year grant with the potential of $10.5 million over the five years. This is the second five-year grant that C-Path has received from the FDA under the...

2014-09-17 08:31:00

HAYWARD, Calif., Sept. 17, 2014 /PRNewswire/ -- Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the RYTARY(TM) (IPX066) New Drug Application (NDA) from October 9, 2014, to January 9, 2015. The Company amended the chemical, manufacturing and control (CMC) section of the RYTARY NDA subsequent to...

2014-09-16 23:14:34

Up until August, frustrated patients with prescriptions could not readily order and receive the Cefaly migraine treatment device efficiently. healthbeautydistributors.com as a service has shortened the ordering process for patients through its direct relationship with Cefaly manufacturer. New Jersey (PRWEB) September 16, 2014 Banish headaches forever with the newest item sold through healthbeautydistributors.com, the drug-free, FDA approved Cefaly device for chronic migraine relief and...

2014-09-16 23:11:20

Expert dermatologist Dr. Mitchel Goldman of Cosmetic Laser Dermatology discusses the importance of only using FDA approved dermal fillers. San Diego, CA (PRWEB) September 16, 2014 A recent article discusses the dangers of an injectable substance used as a dermal filler, “Expression”, which has not been approved for cosmetic use. “Expression” was originally put on the market to be used as an intra-nasal splint following rhinoplasty, and was never approved by the FDA for use as a...


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
cacodemon
  • An evil spirit; a devil.
  • A nightmare.
  • In astrology, the twelfth house of a scheme or figure of the heavens: so called from its signifying dreadful things, such as secret enemies, great losses, imprisonment, etc.
'Cacodemon' comes from a Greek term meaning 'evil genius.'
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