Generic Drug Prices on the Rise

Posted on 09. Dec, 2014 by .

According to Vermont Senator, Bernie Sanders (I-VT), the prices of more than 1,200 generic medications increased an average of 448 percent between July 2013 and July 2014. This does not seem logical to the law maker as generic drug manufacturing companies don’t have the high investment in research and development and marketing that impact other [...]

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Five Quick Information Pieces about Ebola

Posted on 25. Nov, 2014 by .

Ebola is all over the news with cases now being reported in New York.  The medical community is working hard to combat Ebola along with political interventions and policy changes such as restricted flights and quarantining of visitors returning from certain locations. Here is a quick list of five pieces of information about Ebola. 1: [...]

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Medical Device Companies: Making the News for All the Wrong Reasons

Posted on 25. Nov, 2014 by .

Recently, several Medical Device companies have been making the news for some record settlements, recalls and court cases: Stryker, the artificial hip implant company, announced that it has reached a settlement of thousands of lawsuits related to those who claimed to be injured by a hip replacement in which the replacement’s ball and cup components [...]

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Using Evaluation to Craft a Better Compliance Training Program

Using Evaluation to Craft a Better Compliance Training Program

Posted on 19. Nov, 2014 by .

Many groups within organizations look to performance measures to determine the impact of an initiative. Sales teams look at sales numbers, number of calls and volume of product sold. Manufacturing organizations look at the quality of goods produced, number of goods produced and safety of employees during the production process. It only makes sense that [...]

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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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