jag009 ★★★ NJ, 2019-12-18 05:45 (1563 d 10:41 ago) Posting: # 20989 Views: 1,452 |
|
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 |