As expected, the FDA has published the draft guidance on standards for paper and electronic data exchange that was mandated by the U.S. Drug Supply Chain Security Act (DSCSA). And the guidance is early–by one day–fulfilling the intent of the FDA as expressed in the DSCSA Data Exchange workshop held last spring (see “The 2014 FDA DSCSA Workshop“).
I will provide my full analysis in upcoming FDANews coverage of the DSCSA. Watch the FDANews website for that!
Happy reading, and happy Thanksgiving!
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
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