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 Food and Drug Administration Health Medical research Pharmaceutical industry Drug safety Clinical research Investigational New Drug Treatment IND Center for Drug Evaluation and Research Drug development Expanded access New drug application |
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Microsoft Worddoc | 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 |