Biologic License Application - Document - PDFSEARCH.IO

First Page		Document Content
Pharmaceutical sciences Center for Drug Evaluation and Research New Drug Application Investigational New Drug Premarket approval Biologic License Application Regulatory requirement Biologic Prescription Drug User Fee Act Food and Drug Administration Medicine Health		Add to Reading List Source URL: www.fda.gov Download Document from Source Website File Size: 10,54 KB Share Document on Facebook

	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 pharmace DocID: 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 in DocID: 1riMu - View Document
	Microsoft Word - 7494fnl.doc DocID: 1qYy2 - View Document
	Microsoft Worddoc DocID: 1qVAJ - View Document