Changes in the Review Period of Drug Application and a Drug Lag from the FDA and the EMA: An Industry Survey in South Korea Between 2011 and 2020. [PDF]
Ther Innov Regul Sci, 2023 Choi H, Lee H, Park B, Kim C, Lee J.
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Drugged driving: Canada’s laws lag behind [PDF]
Canadian Medical Association Journal, 2015 In addition to setting a legal limit for cannabis, experts say that random roadside testing is the best deterrent for drug-impaired driving. Canada has neither. Meanwhile, seven US states, Australia and 16 European countries have set legal limits.
Dane Wanniarachige
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Lag Time for New Innovative, First-in-Class, Drug Approval in Japan
Biological and Pharmaceutical Bulletin, 2022 Early access to novel drugs, regardless of regional differences, is significant for patients worldwide. Although various efforts have been made to reduce the drug lag, it still exists in some regions, including Japan.
Takayuki Miyazaki +4 more
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Understanding Pediatric Drug Lag Time: Review of Selected Drug Package Inserts
Journal of the Pediatric Infectious Diseases Society, 2020 Abstract The wait for a pharmaceutical drug to become approved by the FDA for pediatrics lasts approximately 8 years longer than that for adults. One of the reasons given is the concern that simultaneous pediatric and adult trials may affect licensing in adults.
Aviva, Beleck, Sharon, Nachman
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Regulatory Disparities Between US Accelerated Approval and Japanese Authorization of Oncology Drugs: An Analysis of Evidence Quality [PDF]
Clinical and Translational ScienceWhile the accelerated approval (AA) program in the United States expedites the availability of drugs based on preliminary evidence to fulfill unmet medical needs, it has also raised significant concerns, including a lack of robust evidence of efficacy ...
Maho Iwata, Anju Murayama
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Drug lag for cardiovascular drug approvals in India compared with the US and EU approvals [PDF]
Indian Heart Journal, 2013 Objective: Age-standardized burden of cardiovascular diseases is substantially higher in low and middle-income countries than in high-income countries.
Bhaven C. Kataria +2 more
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Predicting drug inactivation by changes in bacterial growth dynamics [PDF]
npj Antimicrobials and ResistanceStudying how antibacterials operate at subinhibitory concentrations reveals how they impede normal growth. While previous works demonstrated drugs can impact multiple aspects of growth, such as prolonging the doubling time or reducing the maximal ...
Carmen Li +3 more
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Trends, lag and characteristics of rare disease drug approval in the USA and China, 1983-2022. [PDF]
Orphanet J Rare DisWang S +11 more
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Relatlimab: a novel drug targeting immune checkpoint LAG-3 in melanoma therapy
Frontiers in PharmacologyRelatlimab is a type of human immunoglobulin G4 monoclonal blocking antibody. It is the world’s first Lymphocyte-Activation Gene-3 (LAG-3) inhibitor and the third immune checkpoint inhibitor with clinical application, following PD-1 and CTLA-4 ...
Jingjing Su +7 more
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Study on Drug Lag Using Public Data
Iryo To Shakai, 2011 ある国では使用可能な医薬品が他国では使用できない，あるいは使用できるまでに時間がかかるという「ドラッグラグ」が問題となっている。筆者は，米国，EUおよび日本において1999年から2007年の間に承認を取得した新有効成分含有医薬品（以下，新医薬品）398薬剤を対象とし，各地域におけるドラッグラグの現状について比較分析を行った。本研究では，承認年月日などの基本情報のデータソースを各地域の規制当局による公開情報に求めている。本稿では，事例として本研究を紹介しながら，公的情報の有用性と限界について解説を試みた。公的情報を用いた研究は，データが無料で得られるというメリットがあり，データの網羅性，信頼性，完全性が高い。一方，必要な情報をもれなく収集するためには相当な時間と労力を要し ...
Kaori Tsuji
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