Guidance for Industry: Special Protocol Assessment
Rockville, MD: Center for Biologics Evaluation and Research, 2002 May; 10 p. [Online]. Available: http://www.fda.gov/cder/guidance/3764fnl.htm [2003 February 11]
Showing items related by title, author, creator and subject.
Guidance for Industry. IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations: Final Guidance Unknown creator (United States. Food and Drug Administration [FDA]. Office of the Commissioner, 2003-10-21)
Guidance for Industry. Using a Centralized IRB Review Process in Multicenter Clinical Trials. Draft Guidance Unknown creator (United States. Food and Drug Administration [FDA]; Good Clinical Practice Program, Office of the Commissioner [OC]; Center for Drug Evaluation and Research [CDER]; Center for Biologics Evaluation and Research [CBER]; Office of Regulatory Affairs [ORA], 2005-03)