EU
The new article describes in detail the applicable classification approach and highlights the key considerations associated thereto.
FDA
The article addresses the aspects related to the authority’s expectations associated with the respective program.
Australia
The article highlights the key points related to the regulatory status of boundary products in Australia.
EU
The new article highlights the aspects related to the timelines associated with the clinical investigations, the way they should be calculated, and other relevant matters.
FDA
The new article describes in detail the approach to be applied concerning documenting the review process, its completion, and reporting.
SAHPRA
The new article addresses the aspects related to various matters associated with the licensing process for establishment licenses.
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