FDA
The article outlines the key points of the approach to be used in order to improve participation in clinical studies conducted in the US.
Australia
The new article provides additional details on the application process to be followed by the entities interested in designation as conformity assessment bodies, as well as the assessment process associated thereto.
Australia
The article outlines the key points associated with the regulatory requirements for in vitro diagnostic medical devices intended to be marketed and used in Australia.
FDA
The article describes in brief the key points related to the regulatory framework for laboratory-developed tests.
FDA
The new article describes in detail the applicability scope of the new regulatory policy for laboratory-developed tests.
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