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Pending changes to insurance standards for Russian clinical trials
Effective 9/1/10, there are changes to the Federal Drug Law pending in Russia that will have a material effect on the approval and management of clinical trials that are being conducted there. The...
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Preparing for Hurricane Irene
When confronted with an impending storm such as the forecasted Hurricane Irene, many companies find themselves vulnerable and unprepared for loss. This is particularly true in these difficult economic...
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Implementation of Federal Sunshine Law delayed for drug and medical suppliers
The Centers for Medicare and Medicaid Services (CMS) released guidance back in December regarding the implementation of the Federal Sunshine Law and the proposed timing. Since then, the timeline for...
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Death toll prompts push for tighter federal regulations for compounding...
The recent meningitis outbreak linked to contaminated injections has led to many complaints about Food and Drug Administration (FDA) regulation and oversight of the compound pharmaceutical industry....
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As Ebola threats continue, insurance options respond – or will they?
While the current Ebola pandemic still remains primarily isolated to West Africa, the death of Thomas Duncan earlier this month in Texas has raised many concerns relative to the potential spread of the...
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Chief Legal Officers show concern for patent trolls, data breaches, ethics...
Ethics and compliance top the list of issues plaguing the nation’s top in-house counsel and chief legal officers for 2015. According to a survey from The Association of Corporate Counsel (ACC), 96% of...
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Takeda Pharmaceutical agrees to settlement concerning diabetes drug Actos
On Tuesday April 28, Japan’s Takeda Pharmaceutical agreed to a $2.4 billion settlement involving thousands of lawsuits from patients and their family members claiming that the company’s diabetes drug...
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