FDA Resources

Guidance for Industry: Bioanalytical Method Validation, FDA CDER, May 2001
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070107.pdf

FDA Investigational New Drug application form
http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/forms/ucm083533.pdf

Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including
Well-Characterized, Therapeutic, Biotechnology-derived Products
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulator yInformation/Guidances/ucm071597.pdf

Structure and content of clinical study reports
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073113.pdf

FDA Meeting Guidance
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulator yInformation/Guidances/UCM153222.pdf

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