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Latest Food and Drug Administration Stories

2014-08-28 08:27:37

-- Fujifilm's pAVEway(TM) Platform Demonstrated >25-fold Improvement in SYN-004 Expression Titers -- ROCKVILLE, Md., Aug. 28, 2014 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases, and FUJIFILM Diosynth Biotechnologies UK Limited (Fujifilm), announced today confirmation of exceptional results from the initial phase of cGMP manufacturing of...

2014-08-27 23:03:35

New study “Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices (2014 Edition)” developed by Access China Management Consulting is now available MarketPublishers.com. London, UK (PRWEB) August 27, 2014 China’s regulatory framework for medical devices is going through a period of dramatic changes. The country’s new leaders have admitted that the regulations for supervision and administration of medical...

2014-08-27 12:30:03

LYNDHURST N.J. and NINGBO, China, Aug. 27, 2014 /PRNewswire/ -- Amerigen Pharmaceuticals Limited ("Amerigen") and the Ningbo Menovo Pharmaceutical Co., Ltd, ("Menovo") today announced they had entered into a collaboration agreement regarding the development of generic pharmaceuticals, primarily targeting the United States market. Under the terms of the agreement, Amerigen and Menovo will jointly develop products for Amerigen to commercialize in the United States. Menovo will be...

2014-08-27 08:28:22

THOUSAND OAKS, Calif., Aug. 27, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the U.S. Food and Drug Administration (FDA) has granted priority review designation for ivabradine for the treatment of chronic heart failure (HF). Ivabradine is an oral drug that inhibits the I(f) current ("funny" current) in the sinoatrial node, the body's cardiac pacemaker.(1) Ivabradine works to slow the heart rate without negative effects on myocardial contractility or ventricular...

2014-08-27 08:27:21

REDWOOD CITY, Calif., Aug. 27, 2014 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that senior management will be participating at the FBR Healthcare One on One Conference and presenting at the Morgan Stanley Global Healthcare Conference. Details of the two events are as follows: FBR Healthcare One...

2014-08-26 23:16:04

Lightning Labels Can Help Food Manufacturers Comply with New Guidelines Denver, CO (PRWEB) August 26, 2014 Food manufacturers that sell products in the United States may have to take another look at their food product labels in light of the Food and Drug Administration's new labeling laws affecting the use of the term "gluten-free." Lightning Labels, a custom label and sticker printing company, can help companies as they look to adjust their product labels to comply with the...

2014-08-26 23:14:22

Testosterone Therapy Lawsuits Continue as AndroGel Manufacturer, AbbVie Inc., Attempted to Block Perrigo’s Generic Testosterone Product from Getting FDA Approval Reports Wright & Schulte LLC Columbus, OH (PRWEB) August 26, 2014 As AbbVie faces testosterone therapy lawsuits, Wright & Schulte LLC has learned that the manufacturer of AndroGel has filed a petition against the U.S. Food & Drug Administration (FDA) for granting bioequivalence status to Perrigo Israel...

2014-08-26 23:14:00

Under the guidance of QSIT expert Julie Larsen, Principal/Director, Inspection Readiness Services at BioTeknica, attendees will share best practices on how industry uses of this inspection tool. Participants will break into groups where they will examine challenging scenarios and relate them to how they and their companies manage inspections. Falls Church, VA (PRWEB) August 26, 2014 QSIT Secrets to Assure Clean Inspections: A Hands-On Seminar for FDA-Regulated Companies Pre-Conference...

2014-08-26 23:00:28

On August 22, the FDA announced that Gel-E Donut and Squishon 2 gel-filled products, by Children’s Medical Ventures, are recalled (Class I) due to complaints about visible mold. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) August 26, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Gel-E Donut and...

2014-08-26 08:31:28

TORONTO, Aug. 26, 2014 /PRNewswire/ - Apotex Inc., the largest Canadian owned pharmaceutical company, announced today that an arbitration tribunal rejected Apotex's claims that the FDA violated NAFTA by prohibiting imports of Apotex products from two plants in Ontario, Canada. "The FDA's import alert against our Etobicoke and Signet facilities effectively removed Apotex from the US solid-dose drug market for almost two years," said Dr. Jeremy B. Desai, Apotex's President and Chief...


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
omadhaun
  • A fool; a simpleton: a term of abuse common in Ireland and to a less extent in the Gaelic-speaking parts of Scotland.
This word is partly Irish in origin.