Life Science Compliance Update

April

2017

April 2017: Life Science Compliance Update

Written by , Posted in April 2017 LSC Update, This Month in Compliance

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April 2017 LSCU Cover

Issue Summary

As we await the Easter bunny, this month we feature Chris Cobourn’s article on what pharmaceutical manufacturers need to know about 340B programs. Next, we travel around the globe to explore the recent regulatory changes that are impacting the Chinese life sciences market. Finally, we look at several trend setting enforcement actions, including Baxter’s recent cGMP False Claims Act, Teva’s FCPA settlement and the OIG’s new exclusion criteria.


Feature Article

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340B and You – Thoughts on Program Oversight for Pharmaceutical Manufacturers
Chris Cobourn, Managing Director, Huron Life Sciences
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Issue Articles

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Healthcare Reform – Chinese Style
Amy Greenstein, Senior Consultant and Dana Liu, Consultant, Polaris
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Project Exclusion: The OIG’s Latest Attempt to Make Its Exclusion Authority Real
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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Going Back to the Roots of the False Claims Act – Baxter Settles cGMP Allegations
Seth Whitelaw, JD, LL.M., S.J.D., Editor and Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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TEVA – Using Legitimate Distributor Payments to Conceal Bribes
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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The Murky Future of Physician Owned Distributorships (“PODs”)?
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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