FDA-MEDWatch Program Visit / 薬剤疫学
Japanese Journal of Pharmacoepidemiology
;
: 131-140, 1996.
Article
Dans Japonais
| WPRIM
| ID: wpr-375996
ABSTRACT
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 andMethod:
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 andConclusion:
(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.
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Indice:
WPRIM (Pacifique occidental)
langue:
Japonais
Texte intégral:
Japanese Journal of Pharmacoepidemiology
Année:
1996
Type:
Article
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