Clinical trials of Medical Devices – Updates Rega…
There have been so many changes in the clinical trial framework in Italy including four new decrees concerning clinical trials on medical de…
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Indonesia Published News about Filling in Medical Devic…
Ministry of Health (MOH) Indonesia published news about Filling in Medical Devices Dictionary Data. Based on Government Regulation No. 46 of…
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Taiwan Published Guidelines for Decentralized Measures …
Taiwan Food and Drug Administration published Guidelines for Decentralized Measures for the Implementation of Drug Clinical Trials. Below is…
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UK MHRA Published Guidance on Software as a Medical Dev…
UK’s MHRA announced the Software and AI as a Medical Devices Change Programme last year to ensure regulatory requirements for software…
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Italy Publishes News Regarding Q&A Document on Clin…
The Italian Medicines Agency (AIFA) recently published news regarding a new document ‘Questions & Answers Version 1.0’. In o…
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US FDA Announces Webinar to Discuss Decentralized Trial…
US FDA recently released the draft guidance on decentralized clinical trials and has also scheduled a webinar to discuss this draft guidance…
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Philippines Published News Regarding Guidelines on Regu…
The Food and Drug Administration (FDA Philippines) published news regarding guidelines about relying on the decisions of other regulatory ag…
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US FDA Proposed Draft Guidance on DCT for Drugs, Biolog…
The U.S. Food and Drug Administration (FDA) proposed draft guidance that contains its recommendations for implementing decentralized clinica…
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Taiwan Proposed to Use Electronic Manuals Replacing Chi…
Taiwan FDA published new law on Electronic Manuals replacing Chinese Manuals for Medical Devices. The Taiwan Medical Equipment and Cosmetics…
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US FDA: Patient-Focused Drug Development: Incorporating…
US FDA proposed draft guidance titled “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for…
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