Guidance on ANDA Prior-Approval Supplements

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] FDA issued a guidance for industry on ANDA prior-approval supplements (PAS) in line with the performance metric goals outlined in the Generic Drug User Fee Act (GDUFA) “commitment letter” prepared for Congress this fall (read more here).
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