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FDA Guidance Documents for U.S. Food & Drug Administration (

Daily newsbrief journal for November 2012, also see http://www.usdemocrats.com/brief for a global compendium library and follow twitter @usdemocrats


FDA Guidance Documents for U.S. Food & Drug Administration (

Postby admin » Fri Nov 30, 2012 9:52 am

FDA 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Two new draft guidance documents have been posted on the Clinical Trials Guidance Documents page, http://www.fda.gov/RegulatoryInformatio ... 240323.htm.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Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed - Draft Guidance for IRBs, Clinical Investigators and Sponsors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Electronic Source Data in Clinical Investigations - Draft Guidance for Industry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
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