FDA Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products
Title:
FDA Guidance for Industry
Providing Clinical Evidence of
Effectiveness for Human Drugs and
Biological 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/UCM072008.pdf
Document Type:
Guidance for Industry
Content:
This document is intended to provide guidance to applicants planning to file new drug
applications (NDAs), biologics license applications (BLAs), or applications for supplemental
indications on the evidence to be provided to demonstrate effectiveness.