
FDA Diversity Action Plan for Clinical Studies: Specific Aspects
The final article dedicated to Diversity Action Plans describes certain specific aspects pertaining to the matter, emphasizing the key considerations.
The final article dedicated to Diversity Action Plans describes certain specific aspects pertaining to the matter, emphasizing the key considerations.
The new article is dedicated to enrollment goals, highlighting the aspects related to the rationale behind them and the way they should be measured.
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.
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.
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.