Category Archives: compliance

IOM: Curb Fake Meds through Track-and-Trace, but Forget "Counterfeits"

By Jill Wechsler | Published: February 19, 2013
A new report from the Institute of Medicine (IOM) has drawn a lot of attention to the public health dangers of falsified and substandard medicines around the world. The aim is to build support for a range of activities that can limit the spread of fake medicines in the U.S. and help developing nations strengthen [...]
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The Sunshine Act: Cloudier Still?

By Clark Herman | Published: February 7, 2013
With the recent release of the Patient Protection Sunshine Act (PPSA), the Center for Medicare and Medicaid Services (CMS) has established reporting requirements to ensure that drug manufacturers properly disclose payments to physicians in areas of research, continuing medical education, etc. However a key uncertainty is the issue of state pre-emption. While state and local [...]
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Five Compliance Questions to Ask Yourself, from the DOJ

By Ben Comer | Published: January 31, 2013
At CBI’s 10th Annual Pharmaceutical Compliance Congress, Maame Ewusi-Mensah Frimpong, deputy assistant attorney general, consumer protection branch, civil division, at the US Department of Justice, said being compliant means understanding people, and their motivations. Frimpong said non-compliance boils down to a failure of individuals, and offered five questions for chief compliance officers to ask themselves [...]
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2012 US Drug Approvals Best in 16 Years, But will the good times last?

By Clark Herman | Published: January 3, 2013
Coming out of the blizzard of patent expirations, 2012’s total drug approvals climbed to 39, the greatest number from the FDA since 1996. The evidence is now clear that pipeline preparations laid not just within the year but within the past decade are finally yielding results.
Also posted in FDA, Regulatory | 1 Comment

Compliance and Legal Not Always Eye-to-Eye

By Ben Comer | Published: December 19, 2012
As the role and stature of the compliance officer grows, legacy senior management structures and hierarchies can accidentally pit lawyers against one another. What is strictly legal in the context of sales and marketing practices, working with government officials in global markets, and running and reporting on clinical programs, may not always be the [...]
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