FDA Guidance for Industry: INDs for Phase 2 and Phase 3 Studies; Chemistry, Manufacturing, and Controls Information
Titel:
FDA Guidance for Industry: INDs for Phase 2 and Phase 3 Studies; Chemistry, Manufacturing, and Controls Information
Internet:
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 , http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070567.pdf
Dokumentenart:
FDA Guidance for Industry
Inhalt:
INDs for Phase 2 and Phase 3 Studies; Chemistry, Manufacturing, and Controls Information