While I was preparing a DSCSA resource list to be handed out at the Systech Uniquity event in Mumbai next week I stumbled across a document that the FDA recently posted on their website. It is a template for a DSCSA-specific information sharing agreement that is aimed at state agencies, like state boards of pharmacy and probably state’s attorneys’ offices and state bureaus of investigation, etc. The DSCSA contains several clauses that imply data sharing between the FDA and “…appropriate Federal or State official[s]”.
The problem is, the data that would likely need to be shared Continue reading FDA Posts DSCSA-Specific Information Sharing Agreement Template For State Agencies
The FDA is almost 10 months behind in the release of guidance documents for the 
There are lots of mistakes a company can make when designing their solution to comply with pharma serialization and tracing regulations. One of these is to print the unique identifier on the outsert attached to their packaging. An “outsert” is a tightly folded piece of paper that contains very detailed prescribing information intended to inform medical professionals who prescribe, dispense and/or administer the drug. It contains 
The government of Brazil is trying to recover from the poor design of their first attempt at a pharma serialization and tracing regulation, 
The 
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. 
Last week the US FDA 
Last week I listened in on a 