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Sujan Bose

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Competitive Generic Therapies - 180-day exclusivity
ANDA Submissions Prior Approval Supplements Under GDUFA
Facility Readiness: Goal Date Decisions Under GDUFA
Providing Submissions in Electronic Format-Post Marketing Safety Report
Failure-to-Respond-to-an-Abbreviated-New-Drug-Application
Labeling for Dosing Based on Weight or BSA “Dose Banding”.pptx
Presentation on Orange Book Questions and Answers
Patient Labeling for Human Prescription Drug and Biological Products
Presentation on Safety Consideration during Labeling design
Pre-Launch Activities Importation Request (PLAIR)