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규제 업데이트

FDA, EMA, TGA 및 글로벌 규제 동향

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규제 업데이트
2026년 8월 30일•1분 읽기
MHRA March 2024 Letters and Medicine Recalls Summary
A brief overview of letters and notifications sent to UK healthcare professionals about medicines and medical devices in March 2024.
UPDATED
규제 업데이트
2026년 8월 30일•1분 읽기
FDA Discontinues Isoniazid Tablet (ANDA083060)
FDA lists the oral Isoniazid 100 mg tablet from sponsor PERRIGO (ANDA083060) as discontinued, with no reference drug status.
UPDATED
규제 업데이트
2026년 8월 30일•1분 읽기
FDA Approves ACETAZOLAMIDE Oral Tablet (ANDA084840)
The FDA has approved an ANDA for ACETAZOLAMIDE 250 mg oral tablets, with original and multiple supplemental approvals for labeling and manufacturing from 1978 to 2016.
UPDATED
규제 업데이트
2026년 8월 30일•1분 읽기
FDA Approves ANDA076885 for Rabeprazole Sodium
FDA has approved ANDA076885 for Rabeprazole Sodium oral delayed‑release tablets (20 mg) sponsored by Pharmobedient, with multiple labeling submissions approved between 2013 and 2023.
UPDATED
규제 업데이트
2026년 8월 30일•1분 읽기
FDA Approves ANDA078671 for NABUMETONE Oral Tablets
FDA granted approval for ANDA078671 covering prescription NABUMETONE tablets (500 mg and 750 mg) from sponsor Invagen Pharms, manufactured by Exelan Pharmaceuticals and Cipla USA.
UPDATED
규제 업데이트
2026년 8월 25일•1분 읽기
FDA Approves ANDA080094 for TRIPLE SULFOID Oral Tablet (Discontinued)
The FDA approved ANDA080094 for the oral tablet TRIPLE SULFOID, containing trisulfapyrimidines, sulfamerazine, and sulfamethazine, though the product is listed as discontinued.
UPDATED
규제 업데이트
2026년 8월 25일•1분 읽기
MHRA Drug Safety Update: June 2024 Letters and Notifications
The MHRA released a summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
UPDATED
규제 업데이트
2026년 8월 25일•1분 읽기
MHRA August 2024 Drug Safety Update: Summary of Letters and Recalls
The MHRA released a summary of letters and notifications sent to healthcare professionals in August 2024 regarding medicines and medical devices.
UPDATED
규제 업데이트
2026년 8월 25일•1분 읽기
MHRA Drug Safety Update: September 2024 Letters & Recalls
MHRA released a summary of recent letters and notifications to healthcare professionals concerning medicines and medical devices for September 2024.
UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
FDA Grants ANDA Approval for Ciprofloxacin Hydrochloride Tablets (ANDA 076593)
The FDA approved generic ciprofloxacin hydrochloride tablets (250 mg, 500 mg, 750 mg) under ANDA 076593, sponsored by Aiping Pharm and manufactured by Westminster Pharmaceuticals.
UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
Health Canada Authorizes Temporary Import of South Korean BONKY Calcitriol Injection Amid Shortage
Health Canada permits temporary import and sale of South Korean‑authorized BONKY Calcitriol Injection 1 mcg/mL to mitigate a national shortage, highlighting labeling and pack‑size differences.
UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
MHRA publishes Field Safety Notices for 17‑21 August 2026
The UK Medicines and Healthcare products Regulatory Agency released a list of Field Safety Notices covering 17‑21 August 2026.
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