Author: Gary Lerner

Published FDA-UDI Ruling
September 24, 2013

Published FDA-UDI Ruling

FDA Rule for Unique Device Identification System The Food and Drug Administration (FDA) issued a final rule on October 24, 2013 to establish an identification
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UDI Regulation Released for Medical Devices
September 24, 2013

UDI Regulation Released for Medical Devices

The U.S. Food and Drug Administration issued a long-awaited rule on Friday requiring companies to include Unique Device Identifiers, or UDIs, on medical devices. Each
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National Track&Trace Legislation Delayed Until After August Recess
August 2, 2013

National Track&Trace Legislation Delayed Until After August Recess

August 2, 2013. (Washington, DC). It was a setback for House committee chairman Fred Upton, who sought to put Pharmaceutical traceability legislation on the president’s
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Enabling Item Level Serialization: Ten Key Steps to Ensure Success
August 1, 2013

Enabling Item Level Serialization: Ten Key Steps to Ensure Success

Item level serialization (ILS) and traceability fosters supply chain integrity. Whether to expose counterfeits, identify sources of product diversion, improve integrity in the reconciliation of
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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?

Most believe counterfeit products and medications are not present in legitimate distribution channels. Is that a safe bet? Spend enough time investigating brand piracy and
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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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