FDA Indicates Priorities for 2014-2018

Posted on 05. Nov, 2014 by .

The commissioner of the FDA, Margaret A. Hamburg, M.D., recently released an announcement concerning strategic priorities for the FDA. The announcement is available here. In the announcement, Hamburg indicated that the FDA is focusing on what it calls, “five cross-cutting strategic priorities.” These priorities are: Regulatory Science Regulatory science is the science of developing new [...]

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FDA Creates Cloud-based Dashboard Tool

Posted on 30. Oct, 2014 by .

The FDA recently announced an online tool to provide insight into its compliance, inspection, and recall activities. The tool represents a departure from the downloadable spreadsheet-based datasets the FDA previously provided. Instead, the FDA data dashboard presents information in an easy-to-read graphical format. It also provides access to the underlying data allowing anyone interested to [...]

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Poor Quality Medicine from India is a Concern

Posted on 28. Oct, 2014 by .

The manufacturing of quality medicine is an important issue for the world and recent lapses in India are causing concern. According to the New York Times, India is the second-largest exporter of over-the-counter and prescription drugs to the United States. And the country is coming under increased scrutiny by American regulators for safety lapses, falsified [...]

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FDA Enforcement & Business

Fines, Recalls and Penalties are Serious

Posted on 23. Oct, 2014 by .

Companies, doctors and individuals who ignore compliance issues and GMPs, or mislabel products continue to face stiff penalties and even jail time. Here are some examples of recent infractions and associated penalties.   A rheumatologist in Mayfield Village, Ohio was sentenced to probation for importing medications that had not been approved by the Federal Drug [...]

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FDA and CMS Discuss Parallel Review Pilot Program at AdvaMed MedTech Conference

Posted on 20. Oct, 2014 by .

During the AdvaMed MedTech Conference in Chicago (October 6 through 8), I had several conversations with representatives from medtech companies about payer/provider demands. Reimbursement was “top of mind” in several event sessions – in a panel discussion that followed Dr. Margaret Hamburg’s address to attendees, a medical device product developer acknowledged that at this time [...]

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What is Apple Healthkit?

Posted on 02. Oct, 2014 by .

It turns out the Apple Watch and iPhone 6 are not the only Apple innovations that have recently surfaced. Apple has created a tool for developers called HealthKit, which allows health and fitness apps to work together and they are hoping it is the beginning of a health revolution. HealthKit is a back-end framework that [...]

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Four Things You Should Know About Ebola

Posted on 26. Sep, 2014 by .

With all the news and attention that Ebola is receiving because of the recent outbreak in West Africa, it is worth it to everyone to separate some of the facts from the myths of the disease. One What is Ebola? Ebola is the cause of a viral hemorrhagic fever disease and it is an infectious [...]

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Science Fiction Becoming Science Fact

Posted on 22. Sep, 2014 by .

Recently, there has been an increased interest in the creation of products in the Life Science industry that mix traditional Pharmaceuticals and Medical Devices with creative technological tools to create interesting Medical Devices that can save lives, regenerate organs, help people walk and even track information about the habits of a patient.  Sometimes these innovations [...]

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