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Secretary-General of ASEAN meets with Secretary-General of the Gulf Cooperation CouncilASEAN Main Portal
Secretary-General of ASEAN, Dr. Kao Kim Hourn, met with Secretary-General of the Gulf Cooperation Council (GCC), Jasem Al Budaiwi, at the ASEAN Headquarters/ASEAN Secretariat today. They exchanged views on ways to enhance ASEAN-GCC cooperation, particularly through the implementation of the Joint Statement of ASEAN-GCC Read more
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FDA’s FY 2025 User Fee Schedules Notch Increases of Up to 44 PercentRegulatory Affairs
The FDA has posted six user fee schedules for FY 2025 on the Federal Register showing increases of up to 44 percent — the highest being for biosimilars. Read more
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FDA Adds Digital Health Technologies Guidance to Guidance Snapshot Pilot ProgramRegulatory Affairs
FDA recently added resources for the 2023 guidance “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations” to its Guidance Snapshot Pilot Program webpage. Read more
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Quick Notes: Device Clearances — July 30, 2024Regulatory Affairs
This edition of Quick Notes includes FDA clearance for a Signum Surgical anal fistula treatment, a CE Mark for a Roche CGM system, 510(k) clearance of an augmented reality technology platform for use in operating rooms and a software update for ultra-low field brain images. Read more
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Chairman’s Statement of the ASEAN Post Ministerial Conference (PMC) 10+1 Sessions with the Dialogue Partners and Trilateral MeetingsASEAN Main Portal
The ASEAN Post Ministerial Conference (PMC) 10+1 Sessions with ASEAN’s Dialogue Partners, namely Australia, Canada, China, the European Union, India, Japan, New Zealand, the Republic of Korea, the Russian Federation, the United Kingdom, and the United States of America and three separate Trilateral Meetings between Read more
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Chairman’s Statement of the 25th ASEAN Plus Three Foreign Ministers’ MeetingASEAN Main Portal
The 25th ASEAN Plus Three Foreign Ministers’ Meeting was chaired by His Excellency Saleumxay Kommasith, Deputy Prime Minister, Minister of Foreign Affairs of the Lao PDR. Review and Future Direction of ASEAN Plus Three (APT) Cooperation The Meeting noted with satisfaction the progress in APT Read more