Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
5825761 | Clinical Therapeutics | 2012 | 13 Pages |
Abstract
Prior approval by foreign authorities, although important, did not appear to be essential for approval in Japan. However, substantiating safety and effectiveness of agents by means of standard textbooks or guidelines was used consistently to obtain approval for off-label use.
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Authors
Rumiko PhD, Masayuki MD,