FDA
The new article is dedicated to enrollment goals, highlighting the aspects related to the rationale behind them and the way they should be measured.
FDA
The new article pays special attention to the content of Diversity Action Plans, emphasizing the aspects related to the relevant goals.
FDA
The new article describes in detail the applicability scope and also outlines specific considerations for certain groups of patients that require special attention in order to ensure they are properly represented among study participants.
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.
RegDesk is recognized as a Regulatory Intelligence Representative Vendor! Learn more by reading the 2024 Gartner® Market Guide for Regulatory Intelligence Solutions.
Get the report
