FDA Guidance Documents for U.S. Food & Drug Administration (
Posted: Fri Nov 30, 2012 9:52 amFDA Guidance Documents for U.S. Food & Drug Administration (FDA).
Two new draft guidance documents have been posted on the Clinical Trials Guidance Documents page, http://www.fda.gov/RegulatoryInformatio ... 240323.htm.
IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed - Draft Guidance for IRBs, Clinical Investigators and Sponsors
http://www.fda.gov/downloads/Regulatory ... 328855.pdf
Electronic Source Data in Clinical Investigations - Draft Guidance for Industry
http://www.fda.gov/downloads/Drugs/Guid ... 328691.pdf
Two new draft guidance documents have been posted on the Clinical Trials Guidance Documents page, http://www.fda.gov/RegulatoryInformatio ... 240323.htm.
IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed - Draft Guidance for IRBs, Clinical Investigators and Sponsors
http://www.fda.gov/downloads/Regulatory ... 328855.pdf
Electronic Source Data in Clinical Investigations - Draft Guidance for Industry
http://www.fda.gov/downloads/Drugs/Guid ... 328691.pdf