Guideline: INDs for Phase 2 and Phase 3 Studies; Chemistry, Manufacturing, and Controls Information
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| Titel: | INDs for Phase 2 and Phase 3 Studies; Chemistry, Manufacturing, and Controls Information |
| Internet: | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070567.pdf |
| Herkunft/Verlag: | Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/cder/guidance |
| Inhalt: | INDs for Phase 2 and Phase 3 Studies; Chemistry, Manufacturing, and Controls Information |
| Status: | Final |
| Dokumentenart: | FDA Guidance for Industry |
