FDA publishes Guidance for Industry regarding Risk Evaluation and Mitigation

The US Food & Drug Administration (FDA) recently issued the Guidance for Industry "Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications", dated September.

With this document the authority intends to define form and content of Risk Evaluation and Mitigation Strategies (REMS) including supporting documents. Key items are:

  • Content of evaluations and proposed modifications of approved REMS
  • What persons concerned use as REMS documents
  • How one can communicate REMS issues with the FDA

This guidance is about medicinal product safety evaluations as part of a approval application. It is therefore not directly linked to GMP. On 36 pages - related to medicinal product safety - it shows though, that risk management is important to the FDA.

Sven Pommeranz
On behalf of the European Compliance Academy (ECA)

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