FDA Draft Guidance on Real-World Evidence: Regulatory Context
The new article highlights the aspects related to how the regulatory context should be considered when assessing real-world evidence and real-world data.
The new article highlights the aspects related to how the regulatory context should be considered when assessing real-world evidence and real-world data.
The article describes in detail the aspects related to the responsibilities of the parties involved in the distribution process.
The article provides an overview of the new regulation and highlights the key points associated thereto.
The article highlights the key points related to the regulatory status of in vitro diagnostic medical devices. Table of Contents Health Canada, the Canadian healthcare product regulatory authority, has released a draft guidance on determining medical device...
This article highlights what CE marking is, how to obtain it, and the steps to follow to comply with EU regulations. Table of Contents Medical devices manufacturers willing to market products in the European Union (EU), must comply with the regulations established...