The FDA is expected to postpone the enforcement of the DSCSA compliance requirement by one year.
As already anticipated by industry insiders, the FDA is likely to postpone the enforcement of compliance to the "Drug Supply Chain Security Act" by one year, to November 2018. The FDA has published a "Draft Guidance", which will come into effect in a few weeks. This guidance refers to the published policy.
We would be pleased to advise you on the effects that might result for you. Does the temporal proximity to (EU) 2016/161 have an impact on you? Contact us!
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