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Latest Food and Drug Administration Stories

2014-10-29 12:29:13

Despite Strict FDA Approval Process, Product Launches Will Support Market Growth, According to Findings from Decision Resources Group BURLINGTON, Mass., Oct. 29, 2014 /PRNewswire/ -- Decision Resources Group finds that the United States market for surgical hemostats, internal tissue sealants and adhesion barriers will grow rapidly through 2023 to reach a value of nearly $2.9 billion. The market will be driven by both a growing elderly and obese population as well as considerable competitor...

2014-10-29 08:34:44

Validation of manufacturing process changes for the MGuard Prime EPS BOSTON, Oct. 29, 2014 /PRNewswire/ -- InspireMD, Inc. ("InspireMD" or the "Company") (NYSE MKT: NSPR), a leader in Embolic Protection Systems (EPS), today announced that the FDA has approved the Company's submitted IDE amendment for certain manufacturing process changes to the MGuard Prime EPS that were proposed in response to the Company's April 30, 2014 Voluntary Field Action (VFA). InspireMD said while patient...

2014-10-28 23:13:08

Is the de novo process right for a particular medical device? To help manufacturers decide, FDAnews is pleased to present a 90-minute webinar on Nov. 20 that will explain the new one-step de novo procedure and tell manufacturers what they must do to ensure that the petition includes all the data elements and supporting research the FDA requires. Falls Church, VA (PRWEB) October 28, 2014 Device De Novo Reclassification: FDA’s New Direct De Novo Petitions in Action **FDAnews Webinar**...

2014-10-28 23:04:56

MedicinesMexico.com is a Mexico pharmacy online that meets FDA guidelines and offers a number of brand name and generic blood pressure medicines. Through their online pharmacy Mexico, heart disease patients can order budget-friendly medications to help them fight their blood pressure obstacles. Acapulco, Guerrero (PRWEB) October 28, 2014 According to the Mayo Clinic, new research indicates that some blood pressure medications can also provide protection from heart attacks. (Reference:...

2014-10-28 23:02:30

On October 25, the FDA announced that two lots of INTRAVIA containers, by Baxter International, in the U.S. and Canada are recalled due to particulate matter. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) October 28, 2014 AttorneyOne.com, a recognized authority on law, updates the website daily regarding all the latest information from the FDA on INTRAVIA containers. The FDA...

2014-10-27 23:10:32

The FDA's enforcement plan makes it clear: Developing a successful CAPA program has never been more important. FDAnews and Compliance Media, Inc. are offering an advanced version of their previous CAPA investigations class, fully updated to meet tough FDA scrutiny in 2014. Falls Church, VA (PRWEB) October 27, 2014 Conducting Advanced Root Cause Analysis and CAPA Investigations Understanding Advanced Critical Thinking Skills and Innovative Techniques to Improve the Quality of...

2014-10-27 12:30:49

Even the Score Campaign Calls on FDA to Approve Medical Treatment Options for Female Sexual Dysfunction WASHINGTON, Oct. 27, 2014 /PRNewswire-USNewswire/ -- As the Food and Drug Administration begins a two-day, landmark public meeting today on female sexual dysfunction, Even The Score joined thousands of Americans in calling on the FDA to act urgently to address the lack of treatment options for women who suffer from the most common form of female sexual dysfunction (FSD), a...

2014-10-27 08:36:35

Manufacturer of FDA-approved human grade foods launches new social campaign. SAN DIEGO, Oct. 27, 2014 /PRNewswire/ -- The Honest Kitchen, maker of 100% FDA approved human grade pet food, unveils a social media quiz to determine how 'human' US pets really are. The lighthearted quiz will live at www.HowHumanIsYourPet.com for a duration of three weeks beginning October 27, 2014. http://photos.prnewswire.com/prnvar/20141027/154447 Users will answer 10 questions ranging from where...

2014-10-27 08:29:30

CUPERTINO, Calif., Oct. 27, 2014 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) reported today that Pfizer Inc. (NYSE: PFE) announced today that it has notified Pain Therapeutics, Inc. (Nasdaq: PTIE) that Pfizer has decided to discontinue its agreement to develop and commercialize REMOXY(®) (oxycodone) Extended-Release Capsules CII, an investigational extended-release oral formulation of oxycodone. Pfizer will return all rights, including responsibility for regulatory...

2014-10-27 08:28:36

QUÉBEC CITY, Oct. 27, 2014 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced the formal implementation of its own full-time U.S. sales force with field selling of ASCEND Therapeutics US LLC(')s ("ASCEND"), EstroGel(®), scheduled to start the week of November 17, 2014. EstroGel(® )is the leading non-patch transdermal brand of estrogen replacement therapy commercialized in the U.S. The selling of EstroGel(®) by Aeterna Zentaris is part of...


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
barghest
  • A goblin in English folklore, often appearing in the shape of a large dog and believed to portend imminent death or misfortune.
  • A ghost, wraith, hobgoblin, elf, or spirit.
The origin of 'barghest' is not known, but it may be from perhaps burh-ghest, town-ghost, or German Berg-geist (mountain spirit) or Bär-geist (bear-spirit).
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