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Docx send via electronic mail on October 4 2016 to OPDP Nazia Fatima from DOP1 Sakar Wahby. OPDP reviewed the draft PI and has no comments at this time. Combined OPDP and DMPP comments on MG were provided on October 4 2016 under a separate cover. If you have any questions please feel free to contact me Nazia Fatima at 240402-5041 or at Nazia.Fatima fda.hhs. Index Does the submission contain an accurate comprehensive index 314. 50 NDAs/NDA efficacy supplements or under 21 CFR 601. If the FDAAA...
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