FDA Draft Guidance on Third Party Review Program: Evaluation
The new article describes the matters related to periodic evaluations the authority intends to conduct to ensure compliance with the applicable regulatory regiments.
The new article describes the matters related to periodic evaluations the authority intends to conduct to ensure compliance with the applicable regulatory regiments.
The article describes the approach to be followed when submitting information related to sterilizing medical devices intended to be marketed and used in the US.
The article addresses the aspects related to the authority’s expectations associated with the respective program.
The new article describes in detail the approach to be applied concerning documenting the review process, its completion, and reporting.
The new article highlights the aspects related to the review process itself.
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