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Latest Food and Drug Administration Stories

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...

2014-09-08 16:24:57

MEDIA ADVISORY WASHINGTON, Sept. 8, 2014 /PRNewswire-USNewswire/ -- On September 10, AACC will host a webinar with Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the Food and Drug Administration's (FDA's) Center for Devices and Radiological Health to explain the agency's long-awaited proposal for oversight of laboratory developed tests (LDTs). LDTs play an integral role in diagnosing a wide range of medical conditions, including...

2014-09-08 12:29:49

WOODCLIFF LAKE, N.J., Sept. 8, 2014 /PRNewswire/ -- Par Pharmaceutical Companies, Inc. today announced that it has resumed shipping dexmedetomidine hydrochloride (HCl) injection, EQ 100 mcg base/mL, the generic version of Hospira's Precedex(®) Injection. Par immediately resumed shipping after a U.S. District Court lifted a temporary restraining order that was issued in August at Hospira's request. Last month, Par received final approval from the U.S. Food and Drug Administration...

2014-09-08 12:29:15

Now that Childhood Rare Disease Drugs are Profitable, They Might Get Them WASHINGTON, Sept. 8, 2014 /PRNewswire-USNewswire/ -- As we mark the fourth annual observance of National Childhood Cancer Awareness Month, Kids v Cancer celebrates recent achievements in pediatric drug development. The greatest hurdle in battling childhood cancer and rare diseases has long since been the lack of treatments developed specifically for children. Most sick children are left with pass-me-down...

2014-09-08 12:20:37

Companies Combine Expertise and Resources to Advance Medical Countermeasures Development and Manufacturing ANNAPOLIS, Md. and ALACHUA, Fla., Sept. 8, 2014 /PRNewswire/ -- PharmAthene, Inc. (NYSE MKT: PIP) and Nanotherapeutics, Inc., a privately-held biopharmaceutical company, announced today that they have formed a Strategic Alliance to advance the development of certain medical countermeasures for the U.S. biodefense market. Under the Alliance Agreement, each company will contribute its...

2014-09-08 08:30:58

Studies to Investigate Ability of KP201 to Deter Abuse and Reduce Opioid-Induced Constipation CORALVILLE, Iowa, Sept. 8, 2014 /PRNewswire/ -- KemPharm, Inc., a clinical stage biopharmaceutical company focused on the discovery and development of new, safer therapies to treat pain, announced today the initiation of clinical trials of KP201 designed to investigate the drug candidate's ability to deter abuse and reduce opioid-induced constipation. KP201 (benzhydrocodone hydrochloride...

2014-09-08 08:29:19

Mylan Free to Immediately Resume Distribution of Its Generic Precedex Product PITTSBURGH, Sept. 8, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today commented on a ruling by the U.S. District Court for the District of Maryland related to its product, Dexmedetomidine Hydrochloride Injection, 100 mcg (base)/mL, packaged in 200 mcg (base)/2 mL Single-dose Vials, which was approved by the U.S. Food and Drug Administration (FDA) as therapeutically equivalent to Hospira Inc.'s...


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
grass-comber
  • A landsman who is making his first voyage at sea; a novice who enters naval service from rural life.
According to the OED, a grass-comber is also 'a sailor's term for one who has been a farm-labourer.'