Sponsored: FDA Speaks About DSCSA At HDA

Ilisa Bernstein, Pharm.D., J.D., FDA

Last week, Dr. Ilisa Bernstein, Deputy Director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, spoke last week at the Healthcare Distribution Alliance (HDA) Traceability Seminar (see “HDA Traceability Seminar: RxTrace Future Topic List Explodes“).  Her presentation went beyond the simple, tight-lipped, high-level review of the Drug Supply Chain Security Act (DSCSA) that is typical of recent FDA presentations at conferences.  It was a refreshing change.

Continue reading Sponsored: FDA Speaks About DSCSA At HDA

HDA Traceability Seminar: RxTrace Future Topic List Explodes

The 2017 Healthcare Distribution Alliance (HDA) Traceability Seminar is now in our rearview mirror.  We’ll have to wait another full year for the next one.  As usual, this year was filled with the most pertinent presentations and conversations for those interested in serialization and traceability in the US pharma supply chain—particularly in meeting the Drug Supply Chain Security Act (DSCSA).  I use events like this to discover really great new topics that need to be covered in RxTrace in the future, and this year, this event (including the IEEE Blockchain pre-event) resulted in an explosion.  That is, an explosion in the number of good topics to cover. Continue reading HDA Traceability Seminar: RxTrace Future Topic List Explodes

What The TraceLink v HDA Lawsuit Teaches Us About The Value of Supply Chain Master Data

Buried deep inside the complaint filed in federal court last month by TraceLink against the Healthcare Distribution Alliance (HDA) is the heart of the issue (see “Tracelink vs. HDA”).  It’s about the sharing of product master data throughout the supply chain—that is, “Supply Chain Master Data” (SCMD) (see “Supply Chain Data Synchronization and Patient Safety”).  According to TraceLink’s complaint, the closed nature of HDA’s Origin master data sharing service (see “Dawn of HDA’s Origin, The Key to DSCSA Compliance”) is causing problems for vendors of DSCSA compliance solutions, and that will cause end-user companies in the supply chain to pay more for their overall solution. Continue reading What The TraceLink v HDA Lawsuit Teaches Us About The Value of Supply Chain Master Data

The Fall Global GS1 Healthcare Conference

On October 17 – 19, 2017 the global GS1 Healthcare community came together for their fall conference in Chicago, IL.  The conference was packed with practical information for implementing GS1 Standards across every spectrum of the Healthcare industry.  To cover the entire event, I’ve asked Karen Fleshman, Co-founder, COO of the Haskins Advisory Group, to cover the medical device sessions while I cover the pharma sessions.  Let’s hear from Karen first. Continue reading The Fall Global GS1 Healthcare Conference

Tracelink vs. HDA

What a surprise it was to learn yesterday from Phil Taylor of SecuringIndustry that Tracelink, a traceability software vendor, has filed a lawsuit against the Healthcare Distribution Alliance (HDA), a non-profit industry organization representing the larger wholesale distributors in the United States (see SecuringIndustry, “TraceLink sues HDA over control of pharma track-and-trace data”).  I had to check the calendar to see if it was April 1st.

It wasn’t.  Continue reading Tracelink vs. HDA

Sponsored: Bio/Pharma Serialization and Traceability Summit 2017

Back on June 30, 2017, the U.S. FDA extended the product identifier requirements under the Drug Supply Chain Security Act (DSCSA) to November 26, 2018 due to insufficient industry readiness.  This gives the industry an extra full year to make sure their solutions are fully integrated and tested.  Are you ready?  Are you done?  Even those who would have been ready this November are likely to have more to do to make sure their start-ups go smoothly.  What about your European Falsified Medicines Directive (FMD) strategy?  That’s right around the corner too. Continue reading Sponsored: Bio/Pharma Serialization and Traceability Summit 2017

Opioid Epidemic: Root Cause Exposed

Screen-grab of Joe Rannazzisi on 60 Minutes.

The root cause of the US opioid epidemic was made visible on television two Sundays ago.  Did you see it?  I’m referring to the 60 Minutes/Washington Post expose called “The Whistleblower” that aired on Sunday, October 15.  But if you watched that episode with the volume up, odds are you missed the root cause.  Let me explain. Continue reading Opioid Epidemic: Root Cause Exposed

Sponsored: FDA DSCSA Public Meeting Q&A

The two days after the next FDA DSCSA Public Meeting, IQPC will hold their Pharmaceutical Traceability Forum | Interactive event in Washington DC.  The FDA meeting will be on December 5 and 6, and the IQPC event will be on December 7 and 8.  Perfect for attending two vitally important meetings, and only having to travel once.  The Pharmaceutical Traceability Forum | Interactive event includes a slate of excellent speakers who will provide you with their immediate impressions of the FDA meeting that will have just occurred, and the one that was held back in August (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals”). Continue reading Sponsored: FDA DSCSA Public Meeting Q&A

DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer.
The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel
and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating
the positions of any company, organization or individual other than Dirk Rodgers.

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