EMA: IRIS Regulatory & Scientific Information Management Portal
From 19 October 2020, Scientific Advice request with the European Medicines Agency (EMA) must be applied through the IRIS Regulatory
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FDA Data Standardization initiative – REMS in SPL mandatory submission from 28th December 2022
FDA Data Standardization initiative – REMS in SPL mandatory submission from 28th December 2022 FDA has finally published a draft
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