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Latest Food and Drug Administration Stories

2014-07-23 08:30:59

MARIETTA, Ga., July 23, 2014 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, processor and marketer of patent-protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today it has filed its initial Investigational New Drug ("IND") application with the Food and Drug Administration ("FDA"). The IND submission, which was filed yesterday, July 22, 2014, is the Company's initial submission for certain indications...

2014-07-22 08:32:06

New product offers treatment to significant unmet medical need in supportive cancer care DALLAS and NEW YORK, July 22, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a developer of new products for oncology supportive care, announced today that it has received 510(K) marketing clearance from the U.S. Food and Drug Administration (FDA) for ProctiGard(TM), its novel treatment for symptomatic management of rectal mucositis. The Company indicated its development of...

2014-07-22 08:24:01

NORTHBROOK, Ill., July 22, 2014 /PRNewswire/ -- UL (Underwriters Laboratories), a global safety science leader, has announced that the U.S. Food and Drug Administration (FDA) has recognized two UL battery safety standards as consensus standards for medical devices incorporating lithium or nickel-based batteries. The two standards are UL 2054 - Standard for Household and Commercial Batteries, and UL 1642 - Standard for Lithium Batteries (Cells)....

2014-07-22 00:21:39

FDA Should Move Forward in Banning Menthol Cigarettes Based on Conclusions of Its Own Independent Review WASHINGTON, July 21, 2014 /PRNewswire-USNewswire/ -- The Justice Department should immediately appeal today's misguided ruling by a federal judge that concluded three members of the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) had conflicts of interest - or just the appearance of conflicts of interest - and barred the FDA from using a March 2011 report on menthol...

2014-07-21 23:06:38

GIA initiates research coverage on the global “Pediatric Drugs and Vaccines” market, as part of its ongoing multiple research projects on diverse industries and markets. The soon to be released report identifies rising incidence of metabolic conditions, cardiovascular and CNS diseases among children, rising per capita healthcare spends in emerging markets and a strong drug development pipeline, as primary growth drivers in the market. San Jose, California (PRWEB) July 21, 2014 Follow...

2014-07-21 16:26:17

SAN FRANCISCO and DUBLIN, July 21, 2014 /PRNewswire/ -- Medicines360, a non-profit women's health pharmaceutical company, and Actavis plc (NYSE: ACT), a leading global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Medicines360's New Drug Application (NDA) for Levosert(TM) (levonorgestrel), a hormonal intrauterine contraceptive (IUC) for use by women to prevent pregnancy. In June 2013, Medicines360 and...

2014-07-21 12:25:35

SAN ANTONIO, July 21, 2014 /PRNewswire-USNewswire/ -- ADB International Group Inc.: OTCQB: ADBI (ADBI or the Company) today announced a partnership with Austen BioInnovation Institute in Akron (ABIA or the Institute), for the purpose of bringing ADBI's E-QURE BST(TM), a bioelectrical signal therapy device (the E-QURE BST Device), to the U.S. market. The Institute, which has significant expertise in wound healing, clinical trial development and regulatory operations, will conduct a...

2014-07-20 23:01:11

KRS Global Biotechnology, Inc., an FDA registered and inspected 503B Human Outsourcing Facility that specializes in the preparation of drugs no longer commercially available or in short supply, announces today that they are providing the service of compounded nitroglycerin. Boca Raton, FL (PRWEB) July 20, 2014 KRS Global Biotechnology, Inc. is pleased to announce that it is providing the compounding service of nitroglycerin. Aside from authorized international shipments of the drug into...

2014-07-18 23:04:17

Court Issues Transfer Order in Anticipation of Many More Filings DALLAS (PRWEB) July 18, 2014 The number of lawsuits filed involving plaintiffs claiming they suffered adverse health affects after taking drugs associated with testosterone therapy more than doubled from June 6-16, 2014, reports the national law firm of Baron and Budd. On June 6 there were 45 such lawsuits pending in the U.S. District Court of Illinois, but by June 16 there were nearly 100 lawsuits pending. (In re:...

2014-07-18 23:01:23

US authorities are holding imports more than ever before, particularly at ports that have a history of holding products, and imports from India. Attend this invaluable webinar and find out how to be in the “Safe Zone” when it comes to dealing with the FDA and Customs. Falls Church, VA (PRWEB) July 18, 2014 Improving Your FDA Import Success Rate: Tips for Thinking Ahead of the FDA **FDAnews Webinar** Aug. 7, 2014 — 1:30 p.m. – 3:00 p.m. EDT...


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
sough
  • A murmuring sound; a rushing or whistling sound, like that of the wind; a deep sigh.
  • A gentle breeze; a waft; a breath.
  • Any rumor that engages general attention.
  • A cant or whining mode of speaking, especially in preaching or praying; the chant or recitative characteristic of the old Presbyterians in Scotland.
  • To make a rushing, whistling, or sighing sound; emit a hollow murmur; murmur or sigh like the wind.
  • To breathe in or as in sleep.
  • To utter in a whining or monotonous tone.
According to the OED, from the 16th century, this word is 'almost exclusively Scots and northern dialect until adopted in general literary use in the 19th.'
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