FDA Offers New ‘cGMP Declarations’ That Could Fill US Gap In EU GMP Certificates

02 Oct 2018
News

Bowman Cox @bowmancox bowman.cox@informa.com

Executive Summary

US FDA will send ‘cGMP declarations’ to regulatory authorities in other countries where firms want to market drug products made in the US. There is some hope that the declarations will fill in for EU GMP certificates no longer issued for US manufacturing facilities now that there is a US/EU mutual recognition agreement on inspections.

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FDA Offers New ‘cGMP Declarations’ That Could Fill US Gap In EU GMP Certificates

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Executive Summary

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