It’s funny. Here we are waiting for the FDA to publish four new Drug Supply Chain Security Act (DSCSA) guidance documents (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?“), when an unexpected notice is published about an older draft DSCSA guidance document. When I first looked at the title of the notice I had to read it four times before I could get myself to believe what I was seeing.
That’s right, this morning the FDA Continue reading FDA Announces OMB Approval Of One DSCSA Draft Guidance
It’s time to think about what is likely to happen in 2016 with regard to pharma serialization and traceability. As part of that, let me remind you right off the top to fill out the 
Those of you who are paying close attention to the presidential election campaigns in the United States late last week were treated to a news story that may be a preview of stories that will be written at some point after 2023. The story is about the potential game-changing impact of technology on business when competitors are forced to share a data repository. That is, when private data that would be considered strategically valuable, in some way, if a competitor were to gain access to it, is held by an independent third-party.