FDA Guidance for Industry Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products
Title:
FDA Guidance for Industry
Content and Format of
Investigational New Drug
Applications (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/
Document Type:
Guidance for Industry
Content:
Content and Format of
Investigational New Drug
Applications (INDs) for Phase 1
Studies