Draft OIG Compliance Program Guidance for Pharmaceutical Manufacturers
Federal Register 2002 October 3; 67(192): 62057-62067
Showing items related by title, author, creator and subject.
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 Draft Guidance Unknown creator (United States.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)
Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers: Draft Guidance. Guidance for Industry and Reviewers Unknown creator (Center for Drug Evaluation and Research [CDER] (United States) Center for Biologics Evaluation and Research [CBER], 2002-12)