The FDA is almost 10 months behind in the release of guidance documents for the Drug Supply Chain Security Act (DSCSA) as scheduled by Congress (see “FDA DSCSA Deadline Passes Quietly”, “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”, “FDA Speaks At GS1 Connect”, and “FDA Plans Busy Second Half of 2016 With Six DSCSA Draft Guidances Expected”). So far this year the FDA has held one public meeting to collect public and stakeholder input on the pilot that the law mandates (see “FDA To Hold DSCSA Pilots Workshop”, and “The 2016 FDA Pilots Workshop”). The DSCSA requires the FDA to hold at least five public meetings “…to enhance the safety and security of the pharmaceutical distribution supply chain and provide for comment.”
This morning, the FDA announced Continue reading FDA To Hold DSCSA Public Meeting
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 
Everyone who markets drugs in China has been watching for the publication of revised requirements for tracing drugs there since 