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.
ANVISA
Globalization and the rapid advance of new technologies have presented a major challenge to regulators worldwide. Highly complex regulatory developments and the globalized production chain have advanced much faster than the availability of financial and human resources in most regulatory authorities.
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.
