I hope your holidays were filled with love and cheer. Mine were. It was great. So great, in fact, that I did not have time to write a brand new essay for today. Not much has happened lately since we are still awaiting publications from the FDA, the EC and ANVISA (and others), Instead, here is one of my best essays from 2015, reposted as it appeared on August 31, 2015 without modification (see “An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?“). I’m even leaving in the off-season references. If you read this essay back then, you might enjoy it again. If you did not read it back then, I recommend that you read it now. Let me know what you think.
Before we begin, if you have not yet responded to the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz, please to so now. It is open to everyone and the survey will be closed soon.
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.
This morning the FDA is due to publish an announcement for an opportunity to comment on their proposed collection of certain information as part of ongoing requests for exemptions from the linear “
I was on the HDMA’s website last week doing some research for one of my clients, and I found that the HDMA has updated their highly regarded Q&A document that provides answers to questions related to the U.S. 

