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

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 sectors of the supply chain are expected to interact, or “interoperate,” with each other.  Several resources are available, including some from FDA, as well as a fairly comprehensive DSCSA implementation timeline recently released by The Pew Charitable Trusts.  This timeline illustrates the requirements for each supply chain member, as well as how that supply chain member must interact with others in the supply chain.  As the FDA workshop made clear, the better the supply chain members understand their own responsibilities and challenges, as well as the responsibilities and challenges faced by the parties they work with in the supply chain, the better and more interoperable this new system could be.”

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

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