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Diễn biến quy định từ FDA, EMA, TGA và các cơ quan toàn cầu
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16 thg 9, 2026•1 phút đọc
Medtronic Alerts Variation in Reflective Material on Passive Spheres May Impact Navigation Tracking
Medtronic reports a variation in the reflective coating of certain sterile passive spheres, which could affect instrument detection and tracking during navigation procedures.
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16 thg 9, 2026•1 phút đọc
KPA President Kwon urges opposition to government plan expanding telemedicine prescription delivery
The Korean Pharmaceutical Association warns the government’s proposal to extend prescription drug delivery to all telemedicine patients will require legal changes and vows to block it.
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16 thg 9, 2026•1 phút đọc
KPA President Warns Against Expanding Prescription Delivery for All Telemedicine Patients
The Korean Pharmacists Association urges the government to halt plans to broaden prescription drug delivery to all telemedicine patients, citing legal limits and the need for law amendment.
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16 thg 9, 2026•1 phút đọc
Ministry of Health and Welfare appoints Han Young-gyu as Head of Medical Institution Policy Division
On September 7, 2026, the Ministry announced the promotion of Han Young-gyu to manager‑level head of the Medical Institution Policy Division.
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16 thg 9, 2026•1 phút đọc
South Korean Lawmaker Proposes Bills to Shorten Service for Qualified Health Professionals
Lawmaker Lee Kwang‑hee introduced five amendment bills to reduce the three‑year mandatory service for qualified health personnel, aligning it closer to the 18‑month term for regular soldiers.
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16 thg 9, 2026•1 phút đọc
Health and Welfare Ministry Web & Mobile Services Accessibility Certification Status Revealed
Analysis shows 82% of the Ministry’s 177 websites and apps are accessibility certified, leaving 18% uncertified as of August 2026.
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16 thg 9, 2026•1 phút đọc
FDA Submissions for CALAN Verapamil Tablets (NDA 018817)
The FDA record for NDA 018817 lists multiple labeling and manufacturing submissions for CALAN verapamil tablets, all currently marked as discontinued.
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16 thg 9, 2026•1 phút đọc
Recall: Platinum Naturals Easymulti Stress (Men) Vitamin B6 Mislabel
Health Canada has recalled Platinum Naturals Easymulti Stress (Men) capsules (lots 737‑737C) due to incorrect Vitamin B6 labeling. Retailers should remove affected products.
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16 thg 9, 2026•1 phút đọc
FDA Approves Eli Lilly's Humulin R & KwikPen Insulin (BLA018780)
The FDA has approved Eli Lilly’s Humulin R injectable insulin products, including OTC and prescription formulations, under application BLA018780.
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16 thg 9, 2026•1 phút đọc
MHRA Alert: Patient Hoists and Slings Pose Fatal Fall Risk
MHRA reports ongoing fatal and serious harm from patient falls involving hoists or slings, noting an average of two deaths in recent incidents.
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16 thg 9, 2026•1 phút đọc
Month-end claim delays traced to HIRA portal overload, pharmacy group reports
Pharmacies report that health‑insurance claim software experiences delays and network errors at month‑end due to overload of the HIRA medical‑claim portal server.
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16 thg 9, 2026•1 phút đọc
FDA Approves ARGATROBAN Injection (ANDA091665)
The FDA has approved ANDA091665 for ARGATROBAN injection, a prescription anticoagulant submitted by PH HEALTH.