RegDesk Regulatory Roundup -- Medical Device and Pharma

Dec 20, 2023

SAHPRA

SAHPRA Guidelines on Establishment Licensing: Introduction

The article highlights the key points related to the licensing regime for medical device establishments.

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.

FDA Guidance on General Considerations for Animal Studies: Study Design

Dec 20, 2023

FDA

FDA Guidance on General Considerations for Animal Studies: Study Design

The new article highlights the aspects related to the design of animal studies involving medical devices to be considered by the responsible parties in order to ensure the accuracy and reliability of the results.

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

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.

TGA Guidance on Evidence from Comparable Regulators: Inclusion in the ARTG

Dec 19, 2023

Australia

TGA Guidance on Evidence from Comparable Regulators: Inclusion in the ARTG

The article highlights the aspects related to the inclusion of new products in the Australian Register of Therapeutic Goods (ARTG), a country’s register of healthcare products allowed for marketing and use in the country.

FDA Guidance on General Considerations for Animal Studies: Specific Aspects

Dec 19, 2023

FDA

FDA Guidance on General Considerations for Animal Studies: Specific Aspects

The new article highlights the aspects related to the way animal studies should be planned and conducted, including the facility selection, as well as keeping animals during the study

RegDesk Regulatory Roundup

SAHPRA Guidelines on Establishment Licensing: Introduction

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

FDA Guidance on General Considerations for Animal Studies: Study Design

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

TGA Guidance on Evidence from Comparable Regulators: Inclusion in the ARTG

FDA Guidance on General Considerations for Animal Studies: Specific Aspects

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