FDA
The article highlights the key points related to the application process and outlines the most important aspects to be taken into consideration by applicants.
FDA
The article provides an overview of the revised guidance document issued by the US authority to address certain regulatory matters and ensure legal clarity.
FDA
The article provides a general overview of the existing regulatory framework associated with adverse events.
FDA
The article provides a general overview of the existing regulatory framework associated with adverse events.
FDA
The article provides a general overview of the existing regulatory framework associated with adverse events.
FDA
The article describes in detail the approach to be applied with respect to clinical performance testing considerations including, inter alia, the ones associated with treatment parameters and protocols, safety and effectiveness endpoints and data, as well as adverse events
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
