UDI

European Medical Device and In Vitro Diagnostic Medical Device Regulations Conference

December 18, 2017 Christian Souza

Once again I’ve asked Karen Fleshman, co-founder and COO of Haskins Advisory Group, to step in and cover the recent EU MDR and IVDR Conference that focused on Unique Device Identification (UDI). I’ll return after the holidays with more coverage of pharma serialization. Thanks Karen! –Dirk.

On December 4 – 6, 2017, the European Medical Device (MDR) and In Vitro Diagnostic Medical Device (IVDR) Regulations Conference was held in Orlando, FL. The conference was designed to educate, support, and assist US based medical device manufacturers in gaining critical insight on the requirements of the European Union (EU)’s Unique Device Identification (UDI) compliance program. Continue reading European Medical Device and In Vitro Diagnostic Medical Device Regulations Conference →

DSCSA, FDA

FDA DSCSA Public Meeting #2, Still A Gulf

December 11, 2017 Dirk Rodgers

The gulf in expectations and goals exposed in the first FDA Drug Supply Chain Security Act (DSCSA) Public Meeting back in August (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals” and “HDA Schools FDA On DSCSA”) was still visible in the second meeting last week. There is still one more announced meeting scheduled for February 28, 2018 for the FDA and the industry to align (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”). Based on my observations at these first two meetings, I’m not going to hold my breath. The FDA is likely to announce more meetings in 2018.

The FDA did adjust their position on at least one thing after the August meeting. Continue reading FDA DSCSA Public Meeting #2, Still A Gulf →

DSCSA, HDA

HDA Guidelines For Bar Coding In The Pharmaceutical Supply Chain

December 4, 2017 Dirk Rodgers

It has been six years since the Healthcare Distribution Alliance (HDA) updated their full barcode guidelines (see “Updated HDMA Bar Code Guidance: A Must Read”). They just updated it again with major changes over the 2011 version. The new document is called “HDA Guidelines For Bar Coding In The Pharmaceutical Supply Chain” and it is available on HDA’s website here. With the passage of the Drug Supply Chain Security Act (DSCSA) in November of 2013, an update was long overdue.

You are forgiven if you thought the HDA updated the barcode guidelines only one year ago Continue reading HDA Guidelines For Bar Coding In The Pharmaceutical Supply Chain →

FDA Guidance

FDA’s New DSCSA Grandfathering Guidance

November 30, 2017 Dirk Rodgers 2 Comments

I have now read the FDA’s new draft Grandfathering Policy that was published on Monday (see “FDA Publishes DSCSA Grandfathering Guidance Exactly 2 Years Late”) and for the life of me, I can’t figure out why it took two extra years beyond the due date to get it out. Back in September of 2015 I posted an essay that analyzed the options they had in front of them (see “Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL?”). All they really had to do was chose from a short list of events that could trigger the drug’s transition into the pharmaceutical distribution supply chain at the time of the effective date. They had the following options: Continue reading FDA’s New DSCSA Grandfathering Guidance →

FDA Guidance

FDA Publishes DSCSA Grandfathering Guidance Exactly 2 Years Late

November 27, 2017 Dirk Rodgers

Today is November 27, 2017, the four year anniversary of President Obama signing the Drug Quality and Security Act (DQSA) into law (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”), and it is the two year anniversary of the due date for the FDA to publish four guidance documents—one of the four on grandfathering (see “FDA DSCSA Deadline Passes Quietly”). And today they have finally met that requirement, for grandfathering at least. One overdue Drug Supply Chain Security Act (DSCSA) guidance down, three to go (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”, “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?“, and “DSCSA Serialization Delay Eclipses Grandfathering”). (The DSCSA is Part 2 of the DQSA.) Continue reading FDA Publishes DSCSA Grandfathering Guidance Exactly 2 Years Late →

HDA

HDA’s 2017 Manufacturer Serialization Readiness Survey Results

November 20, 2017 Dirk Rodgers

There is a reason so many RxTrace essays have something to do with the Healthcare Distribution Alliance (HDA) (I won’t list them all, but here are two recent ones: “HDA Traceability Seminar: RxTrace Future Topic List Explodes” and “HDA Schools FDA On DSCSA”). It’s because they have their fingers in just about everything related to the US pharma supply chain’s preparation for compliance with the Drug Supply Chain Security Act (DSCSA). HDA members are literally in the “center” of the supply chain, and the organization is at the center of many of the most important initiatives related to meeting the DSCSA, including their Origin master data sharing service (see “Dawn of HDA’s Origin, The Key to DSCSA Compliance”), their future Verification Router Service (VRS) (see “First Meeting of the HDA Verification Router Service Task Force”), and they hold the most important DSCSA conference every year (see “FDA Speaks About DSCSA At HDA”). And their HDA Research Foundation now conducts the most important manufacturer DSCSA serialization readiness survey. They just published the latest one. Let’s take a look at it. Continue reading HDA’s 2017 Manufacturer Serialization Readiness Survey Results →

FDA

HDA Traceability Seminar: RxTrace Future Topic List Explodes

November 13, 2017 Dirk Rodgers

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 →

RxTrace