著者

森本 和滋 川崎 聡子 吉田 易範

出版者

日本薬史学会

雑誌

薬史学雑誌 (ISSN:02852314)

巻号頁・発行日

vol.50, no.1, pp.64-77, 2015 (Released:2020-12-03)

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For 20 years, the Ministry of Health, Labour and Welfare (MHLW, formerly Ministry of Health and Welfare (MHW)) has been trying to increase transparency of the review process for approving reports in order to promote the rational use of newly approved drugs and medical devices. The first Summary Basis of Approval (SBA) was published by MHW in 1994. In 1999, evaluation reports were prepared by MHW and the Pharmaceuticals and Medical Devices Evaluation Center to make them available to the public. In 2005, a notice from the Chief Executive of the Pharmaceuticals and Medical Devices Agency (PMDA) made procedures for public release of information on reviewing applications for new drugs. In 2006, 90 review reports of newly approved drugs and eight medical devices were revealed on PMDA websites. The dissemination of information by the United States Food and Drug Administration (FDA) and that of the European Medicines Agency (EMA) were studied and compared with that of the MHLW and PMDA. While common technical documents (CTD) for new drugs and summary technical documents (STED) for new medical devices have been released by PMDA, such documents are not released by the FDA and EMA. The European Public Assessment Report (EAPR) summary for the public is an interesting questionnaire approach that uses the What, How and Why format. Finally, future proposals for the next decade are also outlined. PMID: 26427100 [Indexed for MEDLINE]

著者

森本 和滋

出版者

日本薬史学会

雑誌

薬史学雑誌 (ISSN:02852314)

巻号頁・発行日

vol.52, no.1, pp.21-29, 2017 (Released:2020-08-09)

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Frances Oldham was born on July 24, 1914 in the town of Cobble Hill on Vancouver Island, British Columbia, Canada. She passed away on August 7, 2015 at the age of 101. Frances attended Leinster Preparatory School in Shawnigan Lake and graduated at the age of 15. She then attended Victoria College and McGill University in Montreal, Canada, earning a Master's Degree in Science in 1935. In March 1936, Dr. Geiling opened a new laboratory of in the Pharmacology Department at the University of Chicago, USA, and Frances was fortunately accepted, creating her path to PhD studies. In September 1937, the sulfanilamide elixir tragedy involving the excipient diethylene glycol (DEG) occurred in the US, leading to 105 deaths. Dr. Geiling’s laboratory participated in the safety animal study, which involved the use of rats given DEG. Frances thought that, if by carefully work such animal studies, future tragedies could be avoided. In 1938, Frances earned a PhD with a thesis featuring the anatomy and pharmacology of the posterior pituitary gland of the nine-banded armadillo. In 1941, she started a new project entitled, The influence of pregnancy on the quinine oxidase of rabbit liver, which was carried out jointly with Dr. Fremont Ellis Kelsey. In 1943, the study was published in the Journal of Pharmacology and Experimental Therapeutics, and Frances married Fremont the same year. In 1946, Frances entered a medical school at the University of Chicago and graduated in 1950.She moved to South Dakota with her husband with two daughters in 1952, and started her internship in early 1953 at the Sacred Heart Hospital at Yankton. In August 1960, De. Frances Kelsey was appointed the newest medical officer of the US Food and Drug Administration (FDA). On September 12 of the same year, William S. Merrel Company submitted a new drug application (NDA) for thalidomide to the US FDA. As a medical officer, Frances had the primary responsibility for evaluating the clinical reports submitted with the NDA, with particular emphasis on safety. Her steadfast refusal to approve the application saved the lives of thousands of US babies. In 1962, President John F. Kennedy presented Dr. Frances Kelsey with an award for Distinguished Federal Civilian Service for preventing thalidomide from being marketed in the US. In September 2010, the FDA honored her with an award named for her, and a promise from FDA Commissioner Margaret A. Hamburg, MD, that the agency will carry on Kelsey’s commitment to science and integrity. Beginning in 2010, some ethics education of training materials began being used to build a sense of mission and responsibility among Japanese pharmacy and medical students. Lessons learned from the lifetime of Dr. Frances Kelsey have received strong feedback from freshmen and sophomores taking related courses.

著者

森本 和滋

出版者

公益社団法人 日本水環境学会

雑誌

水質汚濁研究 (ISSN:03872025)

巻号頁・発行日

vol.14, no.7, pp.426-431, 1991-07-10 (Released:2009-09-10)

参考文献数

5

著者

森本 和滋

出版者

公益社団法人 日本薬学会

雑誌

ファルマシア (ISSN:00148601)

巻号頁・発行日

vol.26, no.8, pp.835-836, 1990-08-01 (Released:2018-08-26)