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Guidance for Industry ANDA Submissions Prior Approval Supplements Under GDUFA DRAFT GUIDANCE
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S.Castelletto,I.P.Degiovanni,V.Schettini,M.Ware,andA.Migdall,\Measurem
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KANREG IX
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ANDA Submissions Refuse to Receive for Lack of Proper Justification of Impurity Limits
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Digital Academic Writing
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