Saturday, November 29, 2014

The DSCSA Standards Guidance is here! « Ag/FDA Blog

Read the full article: The DSCSA Standards Guidance is here! « Ag/FDA Blog:

"With trading partners required on January 1, 2015, to begin exchanging transaction data when covered pharmaceuticals change owners, guidance from the agency was imperative. FDA specifically recognizes that, although the guidance is a “draft,” “the DSCSA clearly intends for stakeholders to rely upon this draft guidance document before finalization.”  As such, FDA is immediately implementing the Draft Guidance."

'via Blog this'

Read the draft guidance:
DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information (PDF - 85KB)

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