Most RxTrace subscribers are aware that the FDA is way overdue to publish four guidance documents mandated by the Drug Supply Chain Security Act (DSCSA) (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?” and “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?” for a list of the missing documents). Two of those four documents could impact how some drug manufacturers deal with the November 27, 2017 deadline for full serialization of prescription drug products, depending on what the FDA says in them.
Every day since the original due date of those documents (November 27, 2015) I have Continue reading One Immediate Impact of President Trump On The FDA
Last week, the 
Because of all the major news and developments over the last six months, it has taken me way too long to fully cover the Healthcare Distribution Alliance’s (HDA’s) 2016 Serialization Readiness Survey of drug manufacturers. In my defense, I did cover it partially in my report of the HDA 2016 Traceability Seminar (see “
Last week, GS1 Healthcare raised the awareness of new documents available on the Russian Federation government website. Actually, the news was contributed to that group by Brian Daleiden of TraceLink, who has been very generous with contributions of news and documents from multiple markets. These Russian documents explain the basis for a voluntary pharma supply chain pilot that the government is beginning this quarter. Of course, these documents are only provided officially in the native Russian language. 
