규제 업데이트
FDA, EMA, TGA 및 글로벌 규제 동향
규제 업데이트
2026년 9월 24일•1분 읽기
Stryker alerts premature battery drain in certain devices
Stryker reports some devices may suffer early battery loss, leading to power issues and coil detachment failure.
규제 업데이트
2026년 9월 24일•1분 읽기
Stryker devices may experience premature battery drain, affecting operation
Stryker reports that some devices can suffer premature battery drain, leading to power failures, weak indicators, or coil detachment issues.
규제 업데이트
2026년 9월 24일•1분 읽기
FDA Approves ANDA214219 for Triazolam Tablets by Ingenus Pharmaceuticals
FDA granted approval for ANDA214219 covering oral Triazolam tablets (0.125 mg and 0.25 mg) manufactured by Ingenus Pharmaceuticals, LLC.
규제 업데이트
2026년 9월 24일•1분 읽기
FDA approves PHOTOFRIN (Porfimer Sodium) injection – NDA020451
FDA granted approval for PHOTOFRIN, a porfimer sodium injectable marketed by Pinnacle Biologics, under application NDA020451.
규제 업데이트
2026년 9월 24일•1분 읽기
FDA Approves Nimodipine ANDA213409 Submitted by ALKEM Labs
FDA has approved ANDA213409 for two oral solution products of nimodipine from ALKEM Labs, with one product receiving prescription status and the other tentative approval.
규제 업데이트
2026년 9월 24일•1분 읽기
FDA Approves ANDA217961 for CARBIDOPA 25mg Oral Tablet
The FDA has approved ANDA217961 for CARBIDOPA 25 mg oral tablets, a prescription product submitted by Regcon Holdings.
규제 업데이트
2026년 9월 24일•1분 읽기
FDA Approves Bionpharma’s Nicardipine Hydrochloride Capsules (ANDA217555)
The FDA granted approval (AP) for Bionpharma Inc.’s nicardipine hydrochloride oral capsules, 20 mg and 30 mg strengths, under application ANDA217555.
규제 업데이트
2026년 9월 24일•1분 읽기
Baxter Issues Urgent Correction for Likorall™ Ceiling-Mounted Patient Lift
Baxter Corp. has issued an urgent correction for its Likorall™ ceiling‑mounted patient lift due to potential motor shaft breakage and reduced safety system performance, which may cause the lift strap to descend faster than expected.
규제 업데이트
2026년 9월 24일•1분 읽기
Baxter Issues Urgent Correction for Likorall™ Ceiling-Mounted Patient Lift
Baxter Corp. alerts users of a potential motor shaft breakage and reduced safety system performance in Likorall™ ceiling lifts, which may cause straps to lower faster.
규제 업데이트
2026년 9월 24일•1분 읽기
FDA Approves ANDA217117 for LIDOCAINE Topical Ointment
The FDA has approved Aurobindo Pharma's LIDOCAINE 5% topical ointment (ANDA217117) for prescription use, with a standard review completed on June 18, 2024.
규제 업데이트
2026년 9월 24일•1분 읽기
FDA Approves Alembic’s Nitrofurantoin Generic Capsules (ANDA211935)
The FDA has approved Alembic Pharmaceuticals’ generic Nitrofurantoin capsules (ANDA211935) for oral prescription use in 25 mg, 50 mg, and 100 mg strengths.
규제 업데이트
2026년 9월 24일•1분 읽기
FDA Approves ANDA211623 for Generic Carbamazepine Extended‑Release Tablets
The FDA has approved ANDA211623 for carbamazepine extended‑release tablets (100 mg, 200 mg, 400 mg) submitted by Unique Pharm, with labeling cleared in Jan 2024.