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Latest Food and Drug Administration Stories

2014-09-09 16:26:55

DUBLIN, Sept. 9, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted to recommend against approval of Actavis' New Drug Application (NDA) for the fixed-dose combination of nebivolol and valsartan for the treatment of hypertension. The committee vote was six to four recommending against approval. Logo - http://photos.prnewswire.com/prnh/20130124/NY47381LOGO...

2014-09-09 16:26:15

WASHINGTON, Sept. 9, 2014 /PRNewswire-USNewswire/ -- The Parenteral Drug Association (PDA) today announced its plans to publish a Technical Report on the prevention and management of drug shortages. Short supplies and disrupted supply chains of critical, life-saving medicines are becoming an increasing problem for healthcare practitioners and patients in recent years. Regulators in the United States and Europe have been reaching out to industry to find ways to mitigate the kinds of shortages...

2014-09-09 12:30:01

PharmaLex Establishes Affiliated U.S. Pharmaceutical Consulting Group to Provide Client Services Specifically For Food and Drug Administration Requirements MANNHEIM, Germany, Sept. 9, 2014 /PRNewswire-iReach/ -- September 9, 2014 - PharmaLex GmbH (www.pharmalex.com) has announced today that Andrew S. Verderame, MBA, RAC, has joined the company as Senior Advisor. He will establish the PharmaLex U.S. affiliate company and lead business development in the U.S. Mr. Verderame brings a...

2014-09-09 12:29:24

The only Chlorhexidine Gluconate/alcohol solution that has received market authorization by the U.S. Food and Drug Administration (FDA) intended for use to disinfect needleless access sites prior to use. ORANGEBURG, N.Y., Sept. 9, 2014 /PRNewswire/ -- PDI, manufacturer of market-leading infection prevention products and solutions, announced the introduction of Prevantics(® )Device Swab, the only Chlorhexidine Gluconate/alcohol solution that has received market authorization from the...

2014-09-09 12:29:13

NORTHVALE, N.J., Sept. 9, 2014 /PRNewswire/ -- ADM Tronics Unlimited, Inc. (OTCQB: ADMT) is expanding its medical device design and engineering capabilities to service increased customer project activities and orders. The decision to expand was made following the near doubling of ADMT's revenues for the first quarter, ended June 30, 2014, of this fiscal year as compared to the same quarter last year. The expansion includes increasing its staff of engineers and the acquisition of...

2014-09-09 12:28:16

WASHINGTON, Sept. 9, 2014 /PRNewswire-USNewswire/ -- Testifying before the House Energy and Commerce Subcommittee on Health today, Alan Mertz, President of the American Clinical Laboratory Association (ACLA), expressed concern to lawmakers that additional, duplicative regulation imposed by the Food and Drug Administration (FDA) on laboratory-developed tests (LDTs) would cause a harmful ripple effect throughout the laboratory industry that could hamper diagnostic discoveries and...

2014-09-08 23:11:39

On September 2, Martin Avenue Pharmacy, Inc. announced that is recalling all in-date compounded sterile preparations due to lack of assurance 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 08, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Compounded Sterile Preparations....

2014-09-08 23:06:47

1WorldSync announces its Global Data Synchronization Network (GDSN®) standards and Unique Device Identification (UDI) solution will be deployed by bioMérieux, a world leader in the field of in vitro diagnostics. Lawrenceville, NJ (PRWEB) September 08, 2014 1WorldSync announces its Global Data Synchronization Network (GDSN®) standards and Unique Device Identification (UDI) solution has been selected by bioMérieux, a world leader in the field of in vitro diagnostics, to...

2014-09-08 23:06:21

With the release of a recent JAMA Psychiatry study showing that psychiatric drugs send nearly 90,000 Americans to emergency rooms annually, Citizens Commission on Human Rights, the leading mental health watchdog, in its latest article says there is a need for consumers to search its Psychiatric Drug Side Effects Database to learn the documented risks of these drugs. Los Angeles, California (PRWEB) September 08, 2014 A recent JAMA Psychiatry study revealed that between 2009 and 2011, there...

2014-09-08 16:25:38

ST. PAUL, Minn., Sept. 8, 2014 /PRNewswire/ -- Prime Therapeutics, LLC (Prime) has submitted comments to the U.S. Food and Drug Administration (FDA) in support of two citizen petitions on the naming of biosimilar drugs. Biosimilars are medically equivalent versions of biologics, used to treat complex illnesses such as cancer. The citizen petitions were filed in 2013 by the Generic Pharmaceutical Association (GPhA) and Novartis. The petitions urged the FDA to adopt a naming system...


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
tessitura
  • The prevailing range of a vocal or instrumental part, within which most of the tones lie.
This word is Italian in origin and comes from the Latin 'textura,' web, structure.