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Latest Food and Drug Administration Stories

2014-09-12 08:25:15

Accomplished regulatory leader to advance Epic's circulating tumor cell (CTC) technology for 510(k) and PMA approvals SAN DIEGO, Sept. 12, 2014 /PRNewswire/ -- Epic Sciences announced today the appointment of Glen Paul Freiberg, RAC as vice president of regulatory affairs and quality assurance. Mr. Freiberg has more than 35 years of FDA-related experience and is recognized as a key leader in successful regulatory and compliance strategies for diagnostic products. Epic's circulating...

contrave
2014-09-12 05:31:01

John Hopton for redOrbit.com - Your Universe Online The Food and Drug Administration (FDA) has approved the weight loss pill Contrave, a medication that will be used to treat obese adults in conjunction with a controlled diet and exercise. It is the third such drug to be approved since 2012, although its predecessors have not sold well and all have considerable potential side effects. An FDA statement advises that Contrave, which works by decreasing appetite, is approved for use in...

2014-09-11 23:12:12

All manufacturers of combination products need to conduct a comprehensive gap analysis and determine where to make changes to their manufacturing operations, SOPs, training programs and quality assurance. Mark the calendar for Wednesday, Oct. 1, for On-Demand access to Suzanne O’Shea’s immensely popular webinar on combination products. Falls Church, VA (PRWEB) September 11, 2014 All manufacturers of combination products need to conduct a comprehensive gap analysis and determine where...

2014-09-11 23:11:35

Three companies—one European, two American—have teamed up to enable European manufacturers of implantable ophthalmic devices to comply with anticipated regulatory demands for ongoing post-market outcomes data. ZURICH, MADISON, WI, and NEW YORK (PRWEB) September 11, 2014 Three companies—one European, two American—have teamed up to enable European manufacturers of implantable ophthalmic devices to comply with anticipated regulatory demands for ongoing post-market outcomes data. In...

2014-09-11 23:08:38

Dr. Amy Baxter, Shark Tank alumni and TEDMED 2014 speaker has been given 510(k) clearance from the Food and Drug Administration for her company's innovative product, Buzzy®. (PRWEB) September 11, 2014 MMJ Labs LLC, the world leader in non-invasive reusable pain relief devices, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) with expanded indications for Buzzy® for the control of pain associated with injections,...

2014-09-11 23:06:23

Leader in Ion Channel Research to have a prominent presence at SPS with particular focus on the Investigational New Drug (IND) application process. Cleveland, Ohio (PRWEB) September 11, 2014 ChanTest will host a sponsored session entitled “The ABC’s of IND’s” at the Safety Pharmacology Society (SPS) Annual Meeting on Monday, October 20th. This session will touch on the shortcomings of the current nonclinical and clinical assays used for cardiac risk assessment, and address some...

2014-09-11 23:02:29

Regulators, pharmaceutical, biotechnology and medical device industry leaders, innovators, thought leaders and other regulatory stakeholders will participate in the Regulatory Affairs Professionals Society’s signature annual event. Rockville, MD, USA (PRWEB) September 11, 2014 The practitioners of a profession that has a profound impact on healthcare around the world, but whose work is not well understood by the general public will gather in Austin, TX, this month when the Regulatory...

2014-09-11 20:21:50

WASHINGTON, Sept. 11, 2014 /PRNewswire/ -- Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the Food and Drug Administration (FDA) has completed its meeting regarding the New Drug Application (NDA) for Saxenda(®), the intended brand name for liraglutide 3 mg, a once-daily human GLP-1 analogue for the treatment of obesity. Based on the data contained in the NDA for Saxenda(®), the FDA asked the panel members to discuss whether...

2014-09-11 04:20:52

DALLAS, September 11, 2014 /PRNewswire/ -- MarketReportsOnline.com adds Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices (2014 Edition) research report of 194 pages to its store. This research not only provides a comprehensive and thorough knowledge of the latest Chinese regulations for imported medical device registration but also introduces the practical operation on how to comply with the Chinese...

2014-09-10 23:13:00

On September 6, the FDA announced that Pharmacy Creations recalled four product lots because they may have the potential of not being sterile. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) September 10, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on prescription preparations. The US FDA announced on...


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
jument
  • A beast of burden; also, a beast in general.
'Jument' ultimately comes from the Latin 'jugum,' yoke.
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