drug Archives - Page 12 of 12 - The DRE Professor

The Differences Between The DSCSA, FDA Rules and Guidance – RxTrace

May 21, 2014

How To Approach, Read, and Interpret the DSCSA Another great educational snippet from Dirk Rodgers (RxTrace). Follow the link below to read his full article. “So let’s apply that to the exchange of Transaction Information TI, Transaction History TI, and Transaction Statements TS that all U.S. pharma supply chain trading partners must do beginning on […]

FDA Law Blog: Interoperably Exchanging Information with FDA: Agency Holds First DSCSA Public Workshop

May 15, 2014

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Follow the link below for a sobering report of the FDA’s first DSCSA public workshop, and the short implementation timeline that faces the supply chain: “Without an issued guidance, however, what are supply chain members to do in the meantime? Perhaps the most important thing to do is to try to understand the DSCSA, and how different […]