Author: Gary Lerner

Recall of 62 Million Diabetes Test Strips
August 1, 2013

Recall of 62 Million Diabetes Test Strips

The Food and Drug Administration is warning patients with diabetes about the recall of 62 million glucose test strips used to measure blood sugar levels.
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Plans to Defeat Piracy?
December 20, 2012

Plans to Defeat Piracy?

Piracy is a business.  High quality counterfeits can wreak havoc on brand integrity and customer loyalty.  Piracy is another form of competition, perhaps more dangerous
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A Serious Threat to Supply Integrity?
December 20, 2012

A Serious Threat to Supply Integrity?

Spend enough time investigating brand piracy and you begin to question everything.  When we first started designing brand integrity solutions for leading branded companies in
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Serialization in a CMO Environment
December 19, 2012

Serialization in a CMO Environment

Strategic Approaches for Becoming Serialization-Ready By Gary Lerner, Todd Applebaum and Jim Dougherty, Clarkston Consulting and BrandSure, LLC Published May 30, 2012, in Contract Pharma;
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Elements of Brand Integrity Management
December 19, 2012

Elements of Brand Integrity Management

Taking a comprehensive approach is necessary to design and develop a successful Brand Integrity program that will effect change in the organization. The figure at
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Doctor Pleads Guilty In Misbranded Cancer Drug Case
December 18, 2012

Doctor Pleads Guilty In Misbranded Cancer Drug Case

US Department of Justice convicts two in cases tying counterfeit cancer drugs to Canadian pharmacy business. On November 15th, Dr. William Kincaid, of Johnson City,
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Pharmacy Owner Pleads Guilty
December 18, 2012

Pharmacy Owner Pleads Guilty

Jose Morales Commits $23 Million Health Care Fraud Jose Carlos Morales co-owner of Pharmovisa, Inc. and PharmovisaMD Inc., pleaded guilty to to paying kickbacks and
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FDA Seeks UDI Amendment Comments
December 17, 2012

FDA Seeks UDI Amendment Comments

FDA-UDI Comment Period closes December 19, 2012 Last month FDA published an amendment to its July 10, 2012 UDI proposed rule (77 FR 40736). Section
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FDA Issues Proposed UDI Regulation
December 17, 2012

FDA Issues Proposed UDI Regulation

July 3, 2012. In response to requirements in legislation that passed Congress with broad bipartisan support, the U.S. Food and Drug Administration proposed that most
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Qualitest Recalls 101 lots of Hydrocodone Bitartrate and Acetaminophen
December 10, 2012

Qualitest Recalls 101 lots of Hydrocodone Bitartrate and Acetaminophen

Qualitest (Endo Health Solutions) Recalls 101 lots of Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg [Posted 12/07/2012] Bottles from the affected lots may contain
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