Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
News|Articles|January 28, 2019
FDA Publishes REMS Assessment Guidance
Author(s)Pharmaceutical Technology Editors
The guidance describes how to develop a REMS Assessment Plan, discusses the impact of REMS on patient access to drugs, and gives recommendations on reporting REMS findings to FDA.
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On January 24, 2019, FDA published
Specifically, the guidance covers assessment categories, selecting metrics and sources of assessment data, and thresholds for REMS effectiveness. The guidance does not discuss the design or development of REMS.
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