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Last updated on April 18, 2014 at 21:21 EDT

Latest Food and Drug Administration Stories

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...

2014-04-02 04:21:27

KALAMAZOO, Mich., April 2, 2014 /PRNewswire/ -- Ablative Solutions, Inc., a privately-held clinical stage company, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Peregrine System(TM) Infusion Catheter. The Peregrine System uses a unique, patent-pending technology to deliver diagnostic and therapeutic agents directly to the perivascular layer that surrounds blood vessels. This region is dynamic and consists of...

2014-04-01 23:03:33

An increase in R&D spending for new technologies will stimulate growth. For this reason, industry research firm IBISWorld has added a report on the Animal Health Biotechnology industry to its growing industry report collection. New York, NY (PRWEB) April 01, 2014 The Animal Health Biotechnology industry is heavily dependent on external funding to drive the technologically sophisticated research that produces new animal healthcare products and services. As such, revenue contracted in...

2014-04-01 16:25:48

CUPERTINO, Calif., April 1, 2014 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced that data for POSIDUR((TM)) (SABER(®)-Bupivacaine), an investigational drug for administration into the surgical site to produce post-surgical analgesia, is being presented at the 39(th) Annual American Society of Regional Anesthetic and Pain Medicine Meeting. The meeting will be held on April 3-6 at the Sheraton Chicago Hotel and Towers in Chicago....

2014-04-01 08:29:19

Expanding Product Offerings; Building IP Portfolio; Seeking Global Marketing Partners NEW YORK, April 1, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) provided investors with a strategic update on its programs and plans for its proprietary mucoadhesive hydrogel platform technology. Access' patented technology surrounds a unique aqueous pseudoplastic liquid with a defined viscosity range, which is beneficial to the treatment of disorders of mucosal tissue, and...

2014-03-31 23:38:53

Clinovo launches new hands-on trainings for SAS programmers to learn how to use CDISC express, the free SAS-based CDISC SDTM mapping tool, and convert clinical data to SDTM standards. Sunnyvale, CA (PRWEB) March 31, 2014 California-based Clinical Research Organization (CRO) Clinovo introduces two new training options for SAS Programmers to learn to utilize CDISC Express. CDISC Express is Clinovo’s CDISC Study Data Tabulation Model (SDTM) Mapping Tool, downloaded over 1,000 times at...

2014-03-31 23:38:39

CDRH has recently overhauled its Office of Compliance — what exactly has changed and what hasn’t? In this exclusive question-and-answer webinar rebroadcast, FDA veteran Steve Niedelman, lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, speaks with Steve Silverman, Director of CDRH’s Office of Compliance, to help device manufacturers understand all the changes. Falls Church, VA (PRWEB) March 31, 2014 CDRH’s Office...

2014-03-31 20:22:33

DUBLIN, April 1, 2014 /PRNewswire/ -- Research and Markets ( http://www.researchandmarkets.com/research/5q5tcr/global_orphan) has announced the addition of the "Concise Analysis of the International Orphan Drug Market Outlook 2018" [http://www.researchandmarkets.com/research/5q5tcr/global_orphan ] report to their offering. (Logo: http://photos.prnewswire.com/prnh/20130307/600769 ) The global pharmaceutical industry has been experiencing a slow growth in recent...

2014-03-31 16:27:39

LA JOLLA, Calif., March 31, 2014 /PRNewswire/ -- Auspex Pharmaceuticals, Inc. (Nasdaq: ASPX), a late clinical stage biopharmaceutical company focused on developing and commercializing novel medicines for the treatment of orphan diseases, today announced that the Company was added to the Russell 2000® Index (as well as the larger Russell 3000® Index) at the close of market on March 31, 2014 as part of the quarterly Initial Public Offering (IPO) update to the Russell indexes. The...

2014-03-31 16:27:30

HAYWARD, Calif., March 31, 2014 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company focused on developing and commercializing products to treat autoimmune diseases, today announced the appointment of Steven Engle to and the departure of Dr. James Healy, MD, PhD from its Board of Directors. "Steve's extensive experience in late-stage clinical development will be an invaluable resource to the Company," said Dr. Christopher S. Henney, Chairman 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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