Tag Archives: product identifier

FDA New NDC Format Public Meeting

I attended the FDA’s New NDC Format Public Meeting last Monday where I presented my open letter that was last Monday’s RxTrace essay (see “An Open Letter To The FDA: New NDC Format Public Meeting”).  After a welcome from Dr. Janet Woodcock, Director, FDA, Center For Drug Evaluation and Research (CDER) and a brief overview of the purpose of the meeting by Paul Loebach of FDA CDER, there were nine presentations from stakeholders and the public.  After each presentation, the FDA panel Continue reading FDA New NDC Format Public Meeting

Drug Verification: EU Vs US

USvsEU flagsDrug verification is at the heart of most pharma serialization regulations.  It is the point at which someone in the supply chain or a patient uses the unique identifier on the drug package to determine that the drug is probably authentic, or definitely is not.  We can tell a lot about the intent of a given serialization regulation by looking at the specific language that determines by whom and when a unique identifier must be verified. Continue reading Drug Verification: EU Vs US