RegDesk Regulatory Roundup

FDA Draft Guidance on Q-Submission Program: Interaction Types

Apr 8, 2024

FDA Draft Guidance on Q-Submission Program: Interaction Types

The new article describes in detail the aspects of the different types of interactions with the authority within the Q-Submission concept, emphasizing their specific features and use cases

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Credibility Evidence Overview

Dec 28, 2023

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Credibility Evidence Overview

The article describes in detail the approach to be applied when assessing the credibility evidence responsible parties are expected to submit.

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Credibility Evidence Overview

Dec 20, 2023

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Credibility Evidence Overview

The article describes in detail the approach to be applied when assessing the credibility evidence responsible parties are expected to submit.

© 2024 RegDesk, Inc. All rights reserved

RegDesk is recognized as a Regulatory Intelligence Representative Vendor! Learn more by reading the 2024 Gartner® Market Guide for Regulatory Intelligence Solutions.