Apr 8, 2024 FDA FDA Draft Guidance on Q-Submission Program: Interaction Types The new article describes in detail the aspects of the different types of interactions with the authority within the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 Read More
Dec 28, 2023 FDA 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. Read More
Dec 20, 2023 FDA 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. Read More