RegDesk Regulatory Roundup -- Medical Device and Pharma

Dec 28, 2023

BfArM

BfArM Guidance on Fast-Track Process for Digital Health Applications: Timeframes

The new article highlights the aspects related to the timeframes the applicants should follow.

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Credibility Evidence Part 1

Dec 28, 2023

FDA

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Credibility Evidence Part 1

A comprehensive overview of three essential aspects of computational modeling: code verification results, model calibration evidence, and bench test validation results.
Each of these plays a vital role in ensuring the accuracy and reliability of computational models in various scientific and engineering domains.

MDA Guidance on Advertisement Approval: Application Details

Dec 28, 2023

Malaysia

MDA Guidance on Advertisement Approval: Application Details

The article highlights the aspects related to the information to be included in the application an interested party should submit.

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

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.

Dec 28, 2023

BfArM

BfArM Guidance on Fast-Track Process for Digital Health Applications: Life Cycle

The article highlights the aspects related to the life cycle of the digital health applications included in the respective directory.

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

Dec 20, 2023

FDA

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

The article provides a general overview of the guidance document issued by the US authority and highlights the key points related to the existing legal framework.

RegDesk Regulatory Roundup

BfArM Guidance on Fast-Track Process for Digital Health Applications: Timeframes

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Credibility Evidence Part 1

MDA Guidance on Advertisement Approval: Application Details

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

BfArM Guidance on Fast-Track Process for Digital Health Applications: Life Cycle

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

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