FDA Guidance Documents Update

Two new draft guidance documents have been posted on the Clinical Trials Guidance Documents page, http://www.fda.gov/RegulatoryInformation/Guidances/ucm240323.htm.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Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed – Draft Guidance for IRBs, Clinical Investigators and Sponsors

Electronic Source Data in Clinical Investigations – Draft Guidance for Industry

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