VOL.27, Suppl XIV 2000　　World wide view on development and evaluation
of switched and direct OTC

Contents
World wide view on development and evaluation of switched and direct OTC
Preface	Shimizu N	i
●Overview on development and evaluation on switched and direct OTC 　 from a world wide stand point of self-medication	Shimizu N	1-19
●Material [Japanese] & [English]
1. Guidance for the development and assessment of “New Nonprescription Drugs”	Shimizu N, et al.	21-39
2. A guideline on changing the classification for the supply of a medicinal product	European Commission	41-56
3. OTC review −Manual of policies and procedures (MAPP6020.5)	FDA/CDER	57-87
(Appendix)
OTC review −Manual of policies and procedures (MAPP6532.1) 　　 −OTC labeling and use studies−	FDA/CDER	89-96
4. Comprehension testing for OTC drug labels 　　 −Goals, methods, target population, and testing environment−	Morris L, Lechter K, Weintraub M, et al.	97-125
5. Over-The-Counter human drugs；labeling requirements；final rule	FDA/CDER	127-64
6. Points to consider for package inserts for OTC Japan, issued by MHW (in Japanese)		165-8
●Instructions for authors [Japanese] & [English]		169-74

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