FDA-MEDWatch Program Visit
スポンサーリンク
概要
- 論文の詳細を見る
Objective : To get first-hand information on and understand MEDWatch, a newly created program of the US FDA, on safety information reporting and management.<BR>Design and Method : Through a visit to the FDA office by Japanese members of the ICH M1 (Medical Terminology) Expert Working Group (EWG) and other concerned experts, and discussion with relevant FDA staffs.<BR>Results and Conclusion : (1) The MEDWatch program was introduced in June 1993, to accelerate the spontaneous reporting of adverse events (AE) to FDA by developing a single Adverse Event Reporting Form, i.e., FDA 3500, for (1) drugs, (2) biologics (except vaccine), (3) medical devices, (4) food, and (5) veterinary medicines; (2) Five responsible sectors in FDA have been working together to develop a smooth flow of information from health care professionals and industries; (3) The remarkable result from the development of this new program is the increased reporting of serious AE; (4) Much efforts have been exerted by FDA on the education of health professionals through various health societies and through publications; (5) Some of the issues which remain unresolved include database integration of NDA and PMS information; (6) Advocacy of the AE concept and importance of reporting thereof by health care professionals and the use of simple, easy-to-fill-out form is recommended in Japan.
- 一般社団法人 日本薬剤疫学会の論文
一般社団法人 日本薬剤疫学会 | 論文
- Do Clinical Trials Always Benefit Patients?
- A Program for Optimizing Product Combination of Injectable Drugs
- タイトル無し
- The Cochrane Collaboration : Strategic Plan (Translation)
- FDA-MEDWatch Program Visit