I look forward to the Healthcare Distribution Alliance (HDA) Traceability Seminar every year because it is where the a very large number of the key members of the US supply chain meet to discuss implementation of the Drug Supply Chain Security Act (DSCSA). Organizations like the HDA, GS1 US and the FDA often save up their significant news and publications throughout the fall so they can release them with big fanfare at this event. This year was no exception. All three of those organizations made news with their announcements this year. Continue reading 2018 HDA Traceability Seminar Recap
Back on July 3, 2018 the FDA issued a notice of “inspectional observations”—known as an “
Two weeks ago, an 
Just ten weeks before the 
Last week the FDA posted final versions of two DSCSA guidance documents, and, a new draft Product Identifier Q&A document. The two final guidance documents include the grandfathering policy and the product identifier compliance policy that delayed enforcement of the product identifier and verification requirements until November 27, 2018. These documents are companions to each other, which is to say that they are pretty tightly related, and that’s why FDA 
There is now little doubt that the 