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![]() Pharmaceutical sciences Prescription Drug User Fee Act FDA Special Protocol Assessment Workload Investigational New Drug Federal Food Drug and Cosmetic Act New Drug Application Claims adjuster Center for Drug Evaluation and Research Food and Drug Administration Medicine Health | Add to Reading List |
![]() | Morphochem’s Investigational New Drug (IND) application accepted by FDA – Novel antibacterial for IV treatment of CDI ready to move to Phase 2 Munich (Germany), June 22, 2016 — Morphochem, a clinical-stage pharmaceDocID: 1uvYN - View Document |
![]() | Guidance for Industry Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic,DocID: 1sDEk - View Document |
![]() | Emergency Use: means the use of a test article on a human subject in a life-threatening situation inDocID: 1riMu - View Document |
![]() | Microsoft Word - 7494fnl.docDocID: 1qYy2 - View Document |
![]() | Microsoft WorddocDocID: 1qVAJ - View Document |