FDA Guidance for Industry Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications
Title:
FDA Guidance for Industry
Exposure-Response Relationships — Study
Design, Data Analysis, and Regulatory
Applications
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/ucm072109.pdf
Document Type:
Guidance for Industry
Content:
This document provides recommendations for sponsors of investigational new drugs (INDs) and
applicants submitting new drug applications (NDAs) or biologics license applications (BLAs) on
the use of exposure-response information in the development of drugs, including therapeutic
biologics.