RegDesk Regulatory Roundup -- Medical Device and Pharma

Sep 14, 2023

FDA Draft Guidance on Devices Intended to Treat Opioid Use Disorder: Patient Population and Medication Use

The new article highlights aspects related to the clinical studies involving devices intended to treat opioid use disorder, namely, the importance of defining the patient population the device should be used for, and also the approach to be applied with respect to...

FDA Draft Guidance on Devices Intended to Treat Opioid Use Disorder: Study Duration and Missing Data

Sep 14, 2023

FDA

FDA Draft Guidance on Devices Intended to Treat Opioid Use Disorder: Study Duration and Missing Data

The new article highlights the aspects related to the determination of study duration, and also to the approach to be followed in order to mitigate the risks associated with missing data. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...

Aug 16, 2023

Asia

HSA on product registration submissions

The article provides an overview of the existing regulatory framework for submissions related to healthcare products. Table of Contents The Health Services Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance...

Aug 16, 2023

FDA

FDA on MDDT (special considerations)

The new article describes in detail the aspects related to the regulatory status of medical device development tools in comparison to medical devices. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...

Aug 16, 2023

Australia and Oceania

TGA on requesting reconsideration

The article describes the approach to be applied when requesting that a regulatory decision be reconsidered. Table of Contents The Therapeutic Goods Administration (TGA or the Agency), the Australian regulating authority in the sphere of healthcare products, has...

Aug 16, 2023

FDA

FDA on OUD devices (overview)

The new article provides an overview of the main points highlighted by the authority in terms of the applicable regulatory requirements and also outlines the aspects to be taken into consideration when following the applicable rules. Table of Contents The Food and...

RegDesk Regulatory Roundup

FDA Draft Guidance on Devices Intended to Treat Opioid Use Disorder: Patient Population and Medication Use

FDA Draft Guidance on Devices Intended to Treat Opioid Use Disorder: Study Duration and Missing Data

HSA on product registration submissions

FDA on MDDT (special considerations)

TGA on requesting reconsideration

FDA on OUD devices (overview)

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