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Latest Food and Drug Administration Stories

2014-07-31 16:27:38

Urges Agency to Avoid Guidance Which Could Stifle Innovation and Impact Patient Access to Diagnosis and Treatment WASHINGTON, July 31, 2014 /PRNewswire-USNewswire/ -- In response to today's announcement that the Food and Drug Administration (FDA) will release a draft guidance in 60 days to regulate laboratory developed tests (LDTs), the American Clinical Laboratory Association (ACLA) urged the agency to exercise caution, and expressed concern that another layer of regulation could...

2014-07-31 16:27:30

WASHINGTON, July 31, 2014 /PRNewswire-USNewswire/ -- The following is a statement of Matthew L. Myers President, Campaign for Tobacco-Free Kids: http://photos.prnewswire.com/prnvar/20080918/CFTFKLOGO A new government study published today shows that 17.4 million Americans - 7.3 percent of U.S. adults - smoke cigars every day, some days or rarely. This study shows that cigar smoking is a serious public health problem that must be addressed through strategies such as Food and Drug...

2014-07-31 12:23:57

LISBON, Portugal, July 31, 2014 /PRNewswire/ -- Hovione today announced that its API plant in Cork, Ireland has successfully passed a pre-approval inspection by the US Food and Drug Administration (FDA). The inspection, carried out by the FDA Consumer Safety Officer, Ms. Britanny Terhar, lasted 5 days as initially planned, started on 21st July and concluded on the 25th. The inspection confirmed the site to be compliant with the principles and guidelines of Good...

2014-07-30 23:14:44

The FDA has refined its understanding and validation for product, software and processes used for medical production. Protomatic demonstrates its method for adopting the four protocol: design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Dexter, MI (PRWEB) July 30, 2014 The methods used to create a stable manufacturing process are based on multiple industrial requirements. When used for medical production, the...

2014-07-30 23:12:55

To survive in today's tough economy and ultra-competitive medical device market, manufacturers need a quality system that works from the get-go. Medical Device Quality & Compliance Institute 2014: Quality Systems and Design Control Training is three-and-a-half days of intensive training on compliance guidance and insight needed to meet FDA standards with confidence. Falls Church, VA (PRWEB) July 30, 2014 Medical Device Quality & Compliance Institute 2014: Quality Systems and...

2014-07-30 16:29:22

TARRYTOWN, N.Y. and PARIS, July 30, 2014 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (EURONEXT: SAN and NYSE: SNY) today announced that the Companies intend to use a U.S. Food and Drug Administration (FDA) rare pediatric disease priority review voucher in connection with the Biologics License Application (BLA) submission for alirocumab. The priority review voucher entitles the holder to designate a BLA for priority review, which provides for an expedited...

2014-07-30 16:21:42

ARLINGTON, Va., July 30, 2014 /PRNewswire-USNewswire/ -- Today, the National Association of Chemical Distributors (NACD) submitted comments to the Food and Drug Administration (FDA) on its proposed rule titled "Sanitary Transportation of Human and Animal Food." The proposed rule would establish requirements for shippers, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food to use sanitary practices to ensure the safety of the food they...

2014-07-30 08:32:52

ENGLEWOOD, Colo., July 30, 2014 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced a positive written response from the FDA in regards to the company's plans to begin production of Ampion(TM) in our new drug manufacturing facility. http://photos.prnewswire.com/prnvar/20120516/MM09116LOGO Dr. Vaughan Clift, Ampio's Chief Regulatory Officer explained, "Satisfying the Chemistry, Manufacturing and Controls (CMC) requirements of a Biological License Application...

smartphone health apps
2014-07-30 03:00:33

SMU Dedman School of Law Download .PDF of full article: Regulation of Mobile Health Technologies Smart phones and mobile devices are on the cusp of revolutionizing health care, armed with mobile health (“mHealth”) apps capable of providing everything from cardiac measurements to sonograms. While tremendous potential exists to broaden access to medical treatment and control costs, several health law experts say in a just-published New England Journal of Medicine (NEJM) report that...

2014-07-29 23:13:58

It’s time for the 9th Annual FDA Inspections Summit, focusing on inspectional readiness. With twin tracks for drug/biologics and device manufacturers, attendees will discover sessions and panels for every FDA-regulated company. Falls Church, VA (PRWEB) July 29, 2014 9th Annual FDA Inspections Summit **Presented by FDAnews** Oct. 22-24, 2014 – Bethesda, MD http://www.fdanews.com/InspectionsSummit2014 What’s the state of FDA’s Quality Metrics Initiative? When will drug and...


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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