There is a long-running tug-of-war going on between GS1 and national governments around the world over how exactly to identify medical products, whether devices or pharmaceuticals. National governments regulate those products to maximize the health of their citizens and so they take a natural interest in how they are identified. They want to eliminate all ambiguity between products within their market. They need to be able to tightly grant market authorization, revoke it and oversee recalls when warranted. To do that effectively, they need a way of clearly and concisely referencing a given product. That same way of referencing the product should also be used for patient education and for healthcare professional prescribing. Bad things happen when mistakes are made in the identification of healthcare products.
GS1 offers a global standard way of identifying Continue reading Product Identification And National Registration Codes
Last week the US FDA 
Last week I listened in on a 
Everyone who markets drugs in China has been watching for the publication of revised requirements for tracing drugs there since 
It is a little surprising that the 
This week I am posting one of my favorite essays from last fall because at this moment, I am in the middle of moving my home and office from one side of the Chicago metro area to the other to be closer to our kids. Also at this moment, the FDA is almost eight months late in publishing the grandfathering guidance that was mandated by the DSCSA. Here it is again.
Don’t worry. It is not my intention to change this pharma/regulatory/technology blog into a political platform, but after the events of last week, I think it is appropriate for all of us to step back and examine how we can make our country better. I believe I can make a positive contribution by explaining my sincere interpretation of #BlackLivesMatter. I first heard the phrase “Black Lives Matter” back in 2012 when 
