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Management: Food and Drug Administration (FDA)
Countries: Japan Health
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Total 261 results found since Jan 2013.
Current Status of Robotic Gastrointestinal Surgery
This article reviews current trends and potential developments in robotic surgery.PMID:37690822 | DOI:10.1272/jnms.JNMS.2023_90-404
Source: Journal of Nippon Medical School - September 10, 2023 Category: Universities & Medical Training Authors: Keisuke Minamimura Keisuke Hara Satoshi Matsumoto Tomohiko Yasuda Hiroki Arai Daisuke Kakinuma Yukio Ohshiro Youichi Kawano Masanori Watanabe Hideyuki Suzuki Hiroshi Yoshida Source Type: research
A review of criteria strictness in "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials"
Vaccine. 2023 Jul 31:S0264-410X(23)00918-0. doi: 10.1016/j.vaccine.2023.07.072. Online ahead of print.ABSTRACTTo assess safety in vaccine development, stricter grading scales, such as the "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" issued by the U.S. Food and Drug Administration (FDA grading scale), are required. However, concern exists that their strictness may lead to an overestimation of some adverse events (AEs). We analyzed the details of AEs in a phase I clinical trial of a preventive vaccine for infectious diseases. In this trial, we observed th...
Source: Vaccine - August 2, 2023 Category: Allergy & Immunology Authors: Motoki Amai Masanori Nojima Yoshikazu Yuki Hiroshi Kiyono Fumitaka Nagamura Source Type: research
Strengthening the Competitiveness of Japan's Pharmaceutical Industry: Analysis of Country Differences in the Origin of New Drugs and Japan's Highly Productive Firm
Biol Pharm Bull. 2023;46(5):718-724. doi: 10.1248/bpb.b23-00107.ABSTRACTImproving the new drug discovery and development capability of the Japanese pharmaceutical industry, which shows a huge trade deficit, is an urgent issue. To tackle this issue and propose remedies, this study analyzed the originators and characteristics of new drugs approved by the Food and Drug Administration (FDA) from 2017 to 2022 and examined the contributions of Japanese companies. Analysis of the establishment year of the companies that created the approved drugs showed that bio-ventures established in the 1990s and 2000s highly contributed to th...
Source: Biological and Pharmaceutical Bulletin - April 30, 2023 Category: Drugs & Pharmacology Authors: Ryo Okuyama Source Type: research
