For the first time since GS1 produced the Drug Pedigree Messaging Standard (DPMS) standard in 2005, GS1 has just published a call-to-action for the formation of a new standards development group to focus on a new pedigree-related standard. The new group will be called the “Pedigree Security, Choreography and Checking Service (PSCCS) Mission Specific Work … Continue reading Should GS1 Continue Developing ePedigree Standards?
Verification Systems under the DSCSA are the things that FDA (and probably state) inspectors are going to look for whenever they visit your facilities from now on. Are you ready? This new draft guidance will help you.
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 … Continue reading FDA Posts DSCSA-Specific Information Sharing Agreement Template For State Agencies
Yesterday the U.S. FDA posted the first issue of the wholesale distributor and third-party logistics provider (3PL) database as mandated by the Drug Supply Chain Security Act (DSCSA). Through this webpage, you can either download the entire database (in .XLS form), or enter a specific query and then download that result set if desired. I … Continue reading FDA Posts Wholesale Distributor and 3PL License Database
This week I have a special treat to share with RxTrace readers. It is an interview I recently conducted with Kosta Tzavaras, author, publisher, leading data management expert in the pharmaceutical industry and Solutions Manager with Phi Systems in Thousand Oaks, California. Kosta is a consultant to pharma and biotech manufacturers specializing in data analytics … Continue reading Detecting Drug Diversion With Data Analytics–An RxTrace Interview With Analytics Expert Kosta Tzavaras
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