Author: Gary Lerner

FDA DSCSA Standards for Interoperable Exchange
December 2, 2014

FDA DSCSA Standards for Interoperable Exchange

Things to Know: Standards for Interoperable Exchange FDA met its DSCSA mandate by publishing a Draft Guidance, “Standards for the Interoperable Exchange of Information for
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New System to Improve US Drug Security?
December 1, 2014

New System to Improve US Drug Security?

FDA Publishes DSCSA Standards for Interoperable Exchange To prevent dangerous drugs from reaching consumers, the FDA knows a new system is necessary to identify and
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Contamination Linked to Indian Deaths
November 19, 2014

Contamination Linked to Indian Deaths

Health officials in India believe that contaminated antibiotics caused the death of more than 13 women and the hospitalization of many more.  According to the
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Using EPCIS to Attain Lot Level Traceability
October 16, 2014

Using EPCIS to Attain Lot Level Traceability

The latest EPCIS Implementation Guideline details how GS1 Standards can best be applied to meet lot-level and item-level traceability requirements as stipulated in the US
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Shortage of Saline Solution may Threaten Hospital Patients
January 23, 2014

Shortage of Saline Solution may Threaten Hospital Patients

The FDA recently warned health care providers of a shortage of saline solution used for intravenous (IV) solutions, such as 0.9% sodium chloride injection.  A
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Drug Supply Chain Security Act Passes
January 23, 2014

Drug Supply Chain Security Act Passes

On the eve of Thanksgiving 2013, a decade’s old struggle to better secure the US drug supply chain was quietly signed into law.  The 113th
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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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