Australia
The article provides a comprehensive overview of the requirements to be followed by a party responsible for a recall when preparing and issuing a sponsor’s customer letter to ensure all the critical safety-related information is appropriately communicated to the addresses.
Canada
The new article describes specific types of changes to medical devices in detail and outlines the critical points related to the regulatory status thereof.
FDA
The article highlights the aspects related to the key considerations for methodologies used in the context of the collection and analysis of real-world evidence.
FDA
The article highlights the aspects related to the definition of shortage and the steps the authority takes to mitigate the associated risks.
FDA
The new article provides additional details regarding specific aspects associated with remote regulatory assessments.
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
