Regulatory Updates
FDA, EMA, TGA and global regulatory developments
Regulatory Updates
Sep 17, 2026•1 min read
Professor Hong Highlights Gaps in Pricing Reform for Chronic Disease Innovative Drugs
Despite focus on rare disease and oncology, Korea's drug price reform still limits innovative treatments for common chronic conditions, says Seoul National University economist.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves NDA011960 for ARISTOCORT Oral Syrup (Triamcinolone Acetate)
The FDA approved NDA011960 for ARISTOCORT oral syrup, a 2 mg/5 mL Triamcinolone Acetate product by Astellas, now listed as discontinued.
Regulatory Updates
Sep 17, 2026•1 min read
FDA NDA050306: Discontinued GEOPEN Injectable Carbenicillin Products
The FDA record NDA050306 lists five GEOPEN injectable carbenicillin products, all marked discontinued.
Regulatory Updates
Sep 17, 2026•1 min read
KPA Emergency Committee prepares action as Seoul pharmacists demand interim assembly over telemedicine drug delivery expansion
Seoul Pharmaceutical Association delegates passed an urgent motion calling for the Korean Pharmaceutical Association to convene an interim general assembly to discuss the government's expansion of telemedicine prescription drug delivery.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA071510 for Clorazepate Dipotassium Oral Capsule
The FDA has approved ANDA071510 for a 7.5 mg oral capsule of clorazepate dipotassium, with the product now listed as discontinued and several labeling supplements approved.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Registers Manufacturing Submissions for Discontinued Ibuprofen Tablet (ANDA 071144)
The FDA’s ANDA 071144 records show a discontinued ibuprofen 200 mg oral tablet and a series of approved manufacturing (CMC) and labeling submissions spanning 1987‑1997.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Multiple Manufacturing and Labeling Submissions for Discontinued Ibuprofen Tablet
The FDA has approved a series of supplemental applications covering manufacturing and labeling for a discontinued 200 mg oral ibuprofen tablet (product 001).
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Lupin Pharmaceuticals' FYAVOLV (Norethindrone Acetate/Ethinyl Estradiol)
The FDA has approved ANDA204213 for FYAVOLV, a prescription oral tablet combining norethindrone acetate and ethinyl estradiol, manufactured by Lupin Pharmaceuticals.
Regulatory Updates
Sep 17, 2026•1 min read
South Korea to Enforce ‘One Pharmacist, One Pharmacy’ Rule from Nov 27
From Nov 27, Korea’s Ministry of Health and Welfare will regulate the ‘one pharmacist, one pharmacy’ principle for both opening and operating pharmacies, with penalties for operating multiple outlets.
Regulatory Updates
Sep 17, 2026•1 min read
Seoul Pharmacists Association Holds Interim Delegate Meeting, Adopts Government Demand Resolution
The Seoul Pharmacists Association convened an interim delegate general meeting, adopted a resolution demanding government action on telemedicine, drug delivery, safety‑stock medicines, and warehouse pharmacies.
Regulatory Updates
Sep 16, 2026•1 min read
Democratic Party policy chief questions legislative basis for expanding remote drug delivery
Jo Won‑jun raises concerns over proposals to amend a law on non‑face‑to‑face prescription drug delivery, citing lack of implementation and safety issues.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Discontinues HALOPERIDOL Injectable (ANDA070802)
The FDA has marked the HALOPERIDOL injectable (product 001) as discontinued under application ANDA070802 submitted by Smith & Nephew.