what feds expect (button)

links to federal statutes

FDASIA: http://blogs.fda.gov/fdavoice/index.php/2015/02/recent-progress-on-demographic-information-and-clinical-trials/
FDASIA Amendments: http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/UCM365544.pdf
Compliance Guidances: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM455957.pdf
Regulatory Information: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm410382.htm
Diversity: http://www.fda.gov/ForPatients/ClinicalTrials/ucm407817.htm