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FDA Issues Final Guidance on Pivotal Trials for Opioid Use Disorder DevicesRegulatory Affairs
The FDA has finalized its guidance on crafting phase 3 clinical trials for devices designed to treat opioid use disorder (OUD), providing sponsors with direction on defining patient populations, recording medication use, monitoring drug use and other elements. Read more
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ASEAN Socio-Cultural Community highlights inclusive, participatory engagement partnerships beyond 2025ASEAN Main Portal
JAKARTA, 8 July – The 5th Meeting of the Ad Hoc Working Group to Develop the ASCC Post-2025 Strategic Plan took place on 8 – 10 July at the ASEAN Headquarters/ASEAN Secretariat in Jakarta. The meeting was co-chaired by Lao PDR and Malaysia, attended Read more
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NMPA Roundup July 2024China Med Device
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in July 2024. These updates are presented by China Med Device, LLC, your partner […] The post NMPA Roundup July 2024 appeared first on China Med Device. Read more
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RWS to be Applicable in GBA: New Regulation on Devices Urgent Use Policy RevealsChina Med Device
The Greater Bay Area (GBA) – with a total population of approximately 71.2 million people (5% of China’s total population) – includes nine mega cities of Guangdong province: Guangzhou, Shenzhen, […] The post RWS to be Applicable in GBA: New Regulation on Devices Urgent Read more
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Draft Guidance Covers Using URRAs in Combo Product ApplicationsRegulatory Affairs
A use-related risk analysis (URRA) can be used in all phases of the medical product lifecycle. Read more
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Secretary-General of ASEAN meets with Chairman and President of Hong Kong Green Finance AssociationASEAN Main Portal
Secretary-General of ASEAN, Dr. Kao Kim Hourn, met with Chairman and President of Hong Kong Green Finance Association, Dr. Ma Jun, on the sidelines of the CGCC World Chinese Entrepreneurs Summit. They discussed the ongoing ASEAN finance initiatives on digitalization, financial inclusion, and sustainability, Read more