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Booming Mobile Health App Market Needs Robust FDA Oversight

Booming Mobile Health App Market Needs Robust FDA Oversight To Ensure Consumer Safety, Confidence

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...

Latest Food and Drug Administration Stories

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...

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...

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 23:00:51

The installation and use of non-clinically regulated Nurse Call Life Safety Systems across Australian healthcare facilities is of growing concern. Perth WA, Australia (PRWEB) July 30, 2014 Recent international changes to the definition and regulation of medical devices have determined Nurse Call Systems to be considered medical devices. Under Australian and international legislation, this requires all Nurse Call Systems to be clinically regulated, audited and certified. This regulatory...

2014-07-29 08:32:38

Recent U.S. FDA 510(K) Clearance and Appointment of New CEO Create Optimal Growth Environment for Company WHEAT RIDGE, Colo., July 29, 2014 /PRNewswire/ -- The BioFusionary Corporation, Inc. (TBC), a medical technology company focused on developing a proprietary electromagnetic induction platform with aesthetic and surgical applications, today announced it entered into an agreement under which TBC will merge with Australia-based Continuation Investments Limited (COT) in an all-stock...

2014-07-29 08:32:31

HAYWARD, Calif., July 29, 2014 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) performed a general GMP inspection and a Pre-Approval Inspection (PAI) for RYTARY(TM )at the Company's Taiwan manufacturing facility from July 21 to July 26, 2014. At the conclusion of the inspection, the FDA issued a Form 483 with ten inspectional observations. The Taiwan facility was approved for product manufacturing by the FDA in...


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
drawcansir
  • A blustering, bullying fellow; a pot-valiant braggart; a bully.
This word is named for Draw-Can-Sir, a character in George Villiers' 17th century play The Rehearsal.
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