FDA Guidance for Industry Q & A Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products
Title:
FDA Guidance for Industry
Q & A
Content and Format of INDs for Phase 1 Studies
of Drugs, Including
Well-Characterized, Therapeutic,
Biotechnology-Derived Products
Origin/Publisher:
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/ , http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078928.pdf
Document Type:
Guidance for Industry
Content:
INDs - Q & A
Content and Format of INDs for Phase 1 Studies
of Drugs, Including
Well-Characterized, Therapeutic,
Biotechnology-Derived Products