FDA Supac guidance for ER [Regulatives / Guidelines]

posted by jag009  – NJ, 2018-09-07 20:31 (1145 d 16:20 ago) – Posting: # 19251
Views: 1,689

Hi,

Question. To support SUPAC (post approval manufacturing site change) filing for ER products, do we need to perform multimedia dissolution testings?

Thanks
John

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