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Latest Food and Drug Administration Stories

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...

2014-09-16 23:03:11

Topical research report “Pediatric Drug Development - Regulatory Challenges and Commercial Opportunities” worked out by CBR Pharma Insights is now available at MarketPublishers.com. London, UK (PRWEB) September 16, 2014 Since the adoption of pediatric legislation, the number of paediatric clinical trials has risen considerably in line with increased investment in R&D for pediatric drugs. In the USA, over 350 product labels include novel paediatric information and more than 130...

2014-09-16 20:27:17

-- Survey Data Requested by FDA for the September 26 Patient-Focused Drug Development Meeting for Idiopathic Pulmonary Fibrosis CHICAGO, Sept. 16, 2014 /PRNewswire-USNewswire/ -- The Pulmonary Fibrosis Foundation (PFF) announced today that it has submitted survey data from more than 1,100 patients and families suffering from pulmonary fibrosis (PF) to the U.S. Food and Drug Administration (FDA) for the Patient-Focused Drug Development Meeting for Idiopathic Pulmonary Fibrosis on...

2014-09-16 12:36:52

WINNETKA, Calif., Sept. 16, 2014 /PRNewswire/ -- Green Cures & Botanical Distribution Inc. (OTC Pink: GRCU) ("Green Cures") announced today that Allcbd.com, the newest member of Green Cures' portfolio of websites, is now receiving and processing orders from customers across the United States. Additionally, Green Cures is pleased to announce that Allbotanical.com is now shipping orders internationally. Subsequently, the company announced the immediate availability of South African-...

2014-09-16 08:30:17

Innovative needle design to enhance patient safety LAWRENCE, Mass., Sept. 16, 2014 /PRNewswire/ -- NxStage® Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today announced its single needle technology, OneSite(TM), has received FDA clearance. http://photos.prnewswire.com/prnvar/20110503/MM94799LOGO The OneSite employs a unique dual lumen needle design offered in both a sharp version with MasterGuard® and a buttonhole version with SteriPick®...

2014-09-15 23:10:01

On September 9, the FDA announced that it requested the recall of sterile drug products by Downing Labs (aka NuVision Pharmacy) due to lack of sterility. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) September 15, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on sterile drug products. Following 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
omadhaun
  • A fool; a simpleton: a term of abuse common in Ireland and to a less extent in the Gaelic-speaking parts of Scotland.
This word is partly Irish in origin.