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Latest FDA Stories

2014-07-31 04:22:59

-- Newly FDA cleared device with limited release placed in Troy based practice is the first in the Midwest! Now fat destruction is available minus downtime and bothersome contour irregularities.. TROY, Mich., July 31, 2014 /PRNewswire/ -- Dr. Kathleen Gilmore, MD, a Troy based physician and founder of Procerus Skin Care with locations in both Ann Arbor and Troy is the first physician in the Midwest to offer the UltraShape(TM), a breakthrough treatment recently FDA cleared for...

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 23:09:59

On July 24, Dancing Star, LLC informed that various snacks are recalled because they contain organic Carob Powder from Ciranda, Inc., which may be contaminated with salmonella. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) July 30, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on snacks. Dancing Star...

2014-07-30 23:01:21

The FDA's enforcement plan makes it clear: Developing a successful CAPA program has never been more important. FDAnews and Immel Resources are offering an advanced version of their previous CAPA investigations class, fully updated to meet tough FDA scrutiny in 2014. Falls Church, VA (PRWEB) July 30, 2014 Conducting Advanced Root Cause Analysis CAPA Investigations Understanding Advanced Critical Thinking Skills and Innovative Techniques to Improve the Quality of Investigations...

2014-07-30 16:29:10

For Accelerated Approval of Therapies for Duchenne Muscular Dystrophy WASHINGTON, July 30, 2014 /PRNewswire/ -- In response to the 106,782 signatures collected through TheRacetoYes.Org petition urging the "FDA to Say Yes to Accelerated Approval for safe, effective therapies for children with Duchenne" muscular dystrophy, the White House issued a statement yesterday by Janet Woodcock, Director, FDA Center for Drug Evaluation and Research. The Race to Yes organizers expressed...

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 23:13:31

On July 25, the FDA informed that GE Healthcare Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC) are recalled because they may fail or provide incorrect CO2 values. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) July 29, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from...

2014-07-29 16:25:56

The World's Most Advanced Laser Technology for Tattoo Removal and Benign Pigmented Lesions Is Now FDA-Cleared To Treat Acne Scars WESTFORD, Mass., July 29, 2014 /PRNewswire/ -- With acne as the most common skin condition affecting more than 60 million Americans today, it is no surprise that 20 million people have severe enough acne to cause scarring (33 percent of sufferers). Cynosure, the leader in aesthetic lasers, announced today that PicoSure is the first and only picosecond laser now...


Word of the Day
lunula
  • A small crescent-shaped structure or marking, especially the white area at the base of a fingernail that resembles a half-moon.
This word is a diminutive of the Latin 'luna,' moon.
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