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Last updated on April 23, 2014 at 10:40 EDT

Latest Food and Drug Administration Stories

2014-04-04 23:29:56

MannKind's AFREZZA takes a big step towards FDA approval. Princeton, NJ (PRWEB) April 03, 2014 PharmApprove, the leading strategic, regulatory, and scientific communications consultancy to the pharmaceutical and biotech industries, congratulates client MannKind Corporation on its successful U.S. Food and Drug Administration (FDA) Endocrine and Metabolic Advisory Committee meeting this week. The committee voted 13 to 1 on April 1 to recommend that MannKind’s AFREZZA® (insulin...

2014-04-04 23:25:40

Cases are not confined to consolidated federal actions. National network of attorneys continues to offer no-cost consultations to consumers seeking compensation over allegations of life-threatening side effects. San Diego, CA (PRWEB) April 04, 2014 http://www.resource4thepeople.com/defectivemedicaldevices/Dialysis-Lawsuit.html Resource4thePeople today announced important new information about how consumers inquiring about whether to file an action similar to lawsuits filed over...

Allergy Pill For Hay Fever Approved By FDA
2014-04-03 05:24:55

redOrbit Staff & Wire Reports - Your Universe Online In a move that could replace allergy shots for some men and women, the US Food and Drug Administration (FDA) announced on Wednesday that it had approved the first tablet for the treatment of hay fever symptoms. The product is known as Oralair, according to USA Today’s Kim Painter, it will only work against certain types of grass pollens and will take multiple months before it starts working – meaning that it will not help...

2014-04-02 23:30:03

Flood Law Group today announced that they are available to investigate claims of birth defects such as cleft palates or cleft lips that could be related to the use of the prescription drug Topamax during pregnancy. The FDA issued a Drug Safety Communication about use of topiramate (the generic version of Topamax) in 2011. Washington, D.C. (PRWEB) April 02, 2014 Flood Law Group announced today that they are now actively investigating claims on behalf of parents whose children were born...

2014-04-02 16:31:56

SAN DIEGO, April 2, 2014 /PRNewswire/ -- Polaris Group announced today that Shaw T. Chen, M.D., Ph.D. has joined Polaris Pharmaceuticals, Inc. (a subsidiary of Polaris Group) as Executive Vice-President of Regulatory Affairs. Dr. Chen had previously been with the United States (US) Food & Drug Administration (FDA) for over 26 years in new drug development as a primary/supervisory medical staff. His achievements at the FDA included management of new drug review divisions, drafting...

2014-04-02 12:31:22

Sights Set on Establishing Global Footprint FAIRFIELD, Conn., April 2, 2014 /PRNewswire/ -- Competitive Technologies, Inc., (OTCQX: CTTC) (CTI), a pain mitigation company, will sell into Europe, the Middle East and North Africa (the "EMENA territory") effective immediately, in an effort to reestablish the global footprint that was compromised by the signing of the 2012 Amended Distribution and Sales Agreement (the "Amendment") between the inventor and the Company....

2014-04-02 08:33:56

ATLANTA, April 2, 2014 /PRNewswire/ -- CryoLife, Inc. (NYSE: CRY), a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that it has received approval of its Investigational Device Exemption (IDE) for PerClot from the United States Food and Drug Administration (FDA). This approval allows CryoLife to begin its pivotal clinical trial to gain approval to commercialize PerClot in the U.S. The Company plans to begin enrollment in...

2014-04-02 08:32:38

BRANFORD, Conn., April 2, 2014 /PRNewswire/ -- New Haven Pharmaceuticals, Inc. (the "Company"), a privately held specialty pharmaceuticals company, today announced the appointment of Larry Dillaha, M.D., to the newly-created position of Executive Vice President Operations. Dr. Dillaha joins the Company from Insys Therapeutics, Inc. (Nasdaq: INSY) where he served as Chief Medical Officer since April 2010. "We are delighted to welcome Larry, who will provide significant insight and...

2014-04-02 08:32:16

SHANGHAI, April 2, 2014 /PRNewswire/ -- The Chinese government on Monday unveiled a new regulation on the supervision of medical equipment in a bid to enhance its safety and effectiveness and safeguard public health. The regulation will come into effect on June 1. (Logo: http://photos.prnasia.com/prnh/20140401/0861402042 ) Under the new rule, medical equipment in China will be registered and divided into three categories based on the potential health risks they might pose for the...

Your Hand Soap Could Be Doing You More Harm Than Good
2014-04-02 08:36:00

Rebekah Eliason for redOrbit.com – Your Universe Online Antimicrobial household products are widely used, but scientists are wondering if they are doing more harm than good. A new study from Arizona State University has assembled evidence suggesting that antimicrobial use brings consumers no measurable benefit. Even more troubling, according to recent research, the lax regulation of these products has caused toxic compounds to spread throughout wildlife and human populations...


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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