FDA Archives

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: General Framework

Dec 20, 2023

FDA

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: General Framework

The new article highlights the aspects related to the general regulatory framework for computational modelling and simulations used in the healthcare sphere in the context of medical device development.

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.

FDA Draft Q&A on Translation of GLP Study Reports: Overview

Dec 19, 2023

FDA

FDA Draft Q&A on Translation of GLP Study Reports: Overview

The new article provides an overview of the existing legal framework for the translation of GLP study reports

FDA Enforcement Policy for PMA and HDE Supplements: Details

Dec 19, 2023

FDA

FDA Enforcement Policy for PMA and HDE Supplements: Details

The present article describes in detail the policy followed by the authority concerning specific supplements.

RegDesk Regulatory Roundup

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

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: General Framework

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

FDA Draft Q&A on Translation of GLP Study Reports: Overview

FDA Enforcement Policy for PMA and HDE Supplements: Details

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