jag009 ★★★ NJ, 2019-12-18 05:45 (1584 d 15:11 ago) Posting: # 20989 Views: 1,478 |
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Hi, Does anyone know of the biowaiver requirements for APAC (Asia pacific) submission? Specifically, a biowaiver for oral solution (a site change waiver). Is it similar to the requirements for USA and EMA (I think so right but would like to get your feedback). thx J |