• 대한화장품학회지
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• 제29권2호
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• pp.79-104
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• 2003

Introducing to the market place, safe and effective product is an important responsibility of clinical investigators as well as regulatory agencies in all developed countries. Products claiming to improve skin wrinkles are no exceptions. To date, Renova(R) (all-trans retinoic acid), Avage(R) (tazarotene), and Botox(R) (botulinum toxin) are the only agents FDA approved to ameliorate wrinkles associated with photoaged skin in the USA. For all three, clinical evaluation of wrinkle severity was the primary endpoint required for the approval process. No sophisticated instrument measurements of wrinkles were required, nor used in the pivotal studies. The Division of Dermatologic & Dental Products of the US FDA (Director, Jonathan Wilkin, MD) is not against the use of mechanical instruments in assessing wrinkle severity. Its position on this issue however, remains that any such device must be grounded in patients' or product users' perspective, which means that the evaluation instrument must be clinically relevant and clinically perceptible. Sophisticated devices that can detect minimal improvement, but imperceptible to the users are considered useless in the eyes of the US FDA. Two instruments that have been tried in some antiwrinkle studies in the USA are silicone replicas and Primos. Despite their sophistications, they have clear limitations; thus have never replaced clinical evaluations in these studies. At most, they have served as secondary measures to provide corroborative data on the clinical efficacy of antiwrinkle products. For the foreseeable future, at least in the USA, careful clinical assessment of wrinkles will continue to serve as the critical benchmark to determine whether an antiwrinkle product has enough efficacy to benefit its users. We must not lose sight of the fact that sophisticated devices are only to serve in generating supportive evidence, and not the primary evidence, in any clinical studies.

• Korean Circulation Journal
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• 제52권10호
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• pp.755-767
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• 2022

Background and Objectives: Cryoballoon catheter ablation for the treatment of patients with symptomatic atrial fibrillation (AF) has been adopted globally, but there are limited multicenter reports of 12-month outcomes in the Korean patient population. This analysis evaluated the clinical performance and safety of cryoballoon ablation (CBA) according to standard-of-care practices in Korea. Methods: This evaluation of Korean patients with AF was conducted within the larger Cryo Global Registry, which is a prospective, multicenter, post-market registry. Freedom from a ≥30-second recurrence of atrial arrhythmias (after a 90-day blanking period until 12 months) and procedural safety were examined in subjects treated with CBA at 3 Korean centers. Results: Overall, 299 patients with AF (60±11 years old, 24.7% female, 50.5% paroxysmal AF) underwent CBA using the Arctic Front Advance cryoballoon. Of those, 298 were followed-up for at least 12 months. Mean procedure-, left atrial dwell- and fluoroscopy time was 76±21 minutes, 56±23 minutes, and 27±23 minutes, respectively. Freedom from AF recurrence at 12 months was 83.9% (95% confidence interval [CI], 76.9-88.9%) in the paroxysmal and 61.6% (95% CI, 53.1-69.0%) in the persistent AF cohort. Rhythm monitoring was performed on average 4.7±1.4 times during the follow-up period. Serious device- or procedure-related adverse events occurred in 2 patients (0.7%). The 12-month Kaplan-Meier estimate of freedom from repeat ablation and cardiovascular-related hospitalization was 93.8% (95% CI, 90.4-96.1%) and 89.7% (95% CI, 85.6-92.7%), respectively. Conclusions: CBA is an efficient, effective, and safe procedure for the treatment of AF patients when used according to real-world practices in Korea.

• Journal of Korean Neurosurgical Society
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• 제63권2호
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• pp.137-152
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• 2020

In spite of the developing endovascular era, large (15-25 mm) and giant (>25 mm) wide-neck cerebral aneurysms remained technically challenging. Intracranial flow-diverting stents (FDS) were developed to address these challenges by targeting aneurysm hemodynamics to promote aneurysm occlusion. In 2011, the first FDS approved for use in the United States market. Shortly thereafter, the Pipeline of Uncoilable or Failed Aneurysms (PUFS) study was published demonstrating high efficacy and a similar complication profile to other intracranial stents. The initial FDA instructions for use (IFU) limited its use to patients 22 years old or older with wide-necked large or giant aneurysms of the internal carotid artery (ICA) from the petrous segment to superior hypophyseal artery/ophthalmic segment. Expanded IFU was tested in the Prospective Study on Embolization of Intracranial Aneurysms with PipelineTM Embolization Device (PREMIER) trial. With further post-approval clinical data, the United States FDA expanded the IFU to include patients with small or medium, wide-necked saccular or fusiform aneurysms from the petrous ICA to the ICA terminus. However, IFU is more restrictive in South Korea than in United States. Several systematic reviews and meta-analyses have sought to evaluate the overall efficacy of FDS for the treatment of cerebral aneurysms and consistently identify FDS as an effective technique for the treatment of aneurysms broadly with complication rates similar to other traditional techniques. A growing body of literature has demonstrated high efficacy of FDS for small aneurysms; distal artery aneurysms; non-saccular aneurysms posterior circulation aneurysms and complication rates similar to traditional techniques. In the short interval since the Pipeline Embolization Device was first introduced, FDS has been firmly entrenched as a powerful tool in the endovascular armamentarium. As new FDS are developed, established FDS are refined, and delivery systems are improved the uses for FDS will only expand further. Researchers continue to work to optimize the mechanical characteristics of the FDS themselves, aiming to optimize deploy ability and efficacy. With expanded use for small to medium aneurysms and posterior circulation aneurysms, FDS technology is firmly entrenched as a powerful tool to treat challenging aneurysms, both primarily and as an adjunct to coil embolization. With the aforementioned advances, the ease of FDS deployment will improve and complication rates will be further minimized. This will only further establish FDS deployment as a key strategy in the treatment of cerebral aneurysms.

• 한국전자거래학회지
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• 제25권2호
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• pp.127-146
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• 2020

해외 선진국은 연구장비의 중요성을 인식하고 연구장비 산업 활성화를 위해 많은 정책적 지원을 하고 있다. 그러나 우리나라는 연구장비산업 활성화를 위한 정책이나 관련 사업을 지원할 수 있는 법률이 없다. 따라서 연구장비산업 활성화를 위한 정책과 사업을 지원하기 위한 입법이 시급하다. 연구장비산업의 글로벌 시장에서 경쟁력을 확보할 수 있도록 별도의 연구장비산업 활성화 특별법을 제정할 필요가 있다고 판단된다. 본 바와 같이 연구장비 산업 육성을 위한 다양한 진흥정책이 개발될 수 있도록 관련 법률에 필요한 사항을 명시해야 한다. 연구장비 산업발전을 촉진하기 위해서는 법에 명시해야 할 필수항목이 세 가지다. 첫째는 연구개발 지원, 둘째는 인프라 개발, 셋째는 비즈니스 육성이다. 각 내용에는 다음과 같은 내용이 포함되어야 한다. 우선 '연구개발 지원'에는 연구개발사업 추진 및 지원 정책항목, 연구장비 개발동향 및 투자동향, 산학관 공동연구, 융·복합·사업화를 위한 연구개발 지원 등이 포함된다. 다음으로 '인프라 개발' 포함될 항목에는 연구장비 클러스터 구축, 관련 지원항목, 전문인력 양성, 연구장비개발기반지역 및 기관 등이 포함되어야 한다. 마지막으로 '사업 육성'에 포함되어야 할 항목은 우수기업 육성 지원사항(우선구매제도 등), 기술이전 및 마케팅 관련 사항, 지식재산 보호에 관한 사항, 해외진출 촉진에 관한 사항 등이다.

• 무역학회지
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• 제48권3호
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• pp.131-150
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• 2023

본 연구는 한국 바이오헬스 산업에 대한 미국의 수입거부(Import Refusals) 대응 방안 모색을 목적으로 한다. 이를 위해 수입거부 품목과 유형에 대한 정보가 포함된 한국무역협회 통관거부사례 데이터베이스를 활용하여 팬데믹 시기의 동향 분석을 시행하였으며, FDA 위반코드(Violation Code)에 따라 거부사유까지 분석하였다. 추가적으로 단위거부율(URR)의 측정을 통해 수입거부 대응 수준도 파악하였다. 분석 결과, 한국 바이오헬스 산업에 대한 미국의 주요 수입거부 품목은 과거 콘택트렌즈에서 코로나-19 이후 진단키트와 의약품으로 확대된 것으로 나타났으며, 주요 수입거부 사유는 의료기기와 의약품 관련법의 규정 미준수와 제품 및 시설에 대한 FDA의 미승인으로 확인되었다. 한편 바이오헬스 주요 품목의 단위거부율은 산업 평균보다 높게 측정되어 미국 수입거부 대응 수준이 낮은 것으로 파악되었다. 또한 FDA 위반코드에 따라 품목별 수입거부 사유를 분석한 결과는 다음과 같다. 우선, 콘택트렌즈와 코로나바이러스 진단키트의 주요 위반사항은 부정표시(Misbranding)에 해당한다. 이는 FDA에 관련 통지나 정보가 규정대로 제공되지 않았거나, 시판 중인 기승인 의료기기(Predicate Device)와 비교하여 본질적 동등성을 입증하지 못한 경우가 많다. 반면, 의약품은 유효성 및 안전성 입증 관련 규정에 따라 신청서의 승인을 받지 못한 미승인 신약(Unapproved New Drug)에 해당한다. 결과적으로 바이오헬스 산업의 수입거부는 무역기술장벽(TBT)과 밀접한 관련이 있다.