Tag Archives: Traceability Models

HDA Questions FDA’s Authority To Mandate A Centralized System For the EDDS

Man in camelhair business suit wearing Question Authority button on left lapelOnce again, the Healthcare Distribution Alliance (HDA) has submitted written comments to the FDA as a follow-up to the FDA’s most recent DSCSA Public Meeting held on December 5-6 (see “HDA Schools FDA On DSCSA”, and “FDA DSCSA Public Meeting #2, Still A Gulf”).  The comments cover seven “issues” HDA wanted to provide further comments on, beyond those already expressed in the public meeting itself and earlier written comments.  The seven issues include:

  1. HDA urges greater appreciation for and recognition of the ‘distributed model’…
  2. HDA recommends topics to address at the February 28 public meeting
  3. We expand upon certain data standard and exchange issues from the December public meeting
  4. …we offer suggestions for where ‘guardrails’ may be useful [to the industry]”
  5. We summarize our understanding of the aggregation and inference discussion at the public meeting…
  6. HDA urges FDA to begin undertaking the small business assessment mandated by the DSCSA
  7. …various other issues raised during the public meeting…

Continue reading HDA Questions FDA’s Authority To Mandate A Centralized System For the EDDS

Pharma Supply Chain Companies Organize To Establish Global Traceability Data Exchange Architecture

rx-360-logoLast Friday a new committee formed by Rx-360 held their first meeting of parties interested in identifying architectures—or at least “conceptual models”—useful for efficiently meeting the full diversity of pharmaceutical track and trace regulations around the globe.  Rx-360 is a non-profit organization “…formed in 2009 to support an industry-wide commitment to ensure patient safety by enhancing quality and authenticity throughout the pharmaceutical supply chain”, according to their press releases.

The new committee is called the “Traceability Data Exchange Architecture Work Group” and it seeks Continue reading Pharma Supply Chain Companies Organize To Establish Global Traceability Data Exchange Architecture