Resources
LINKS
- FDA-US
www.fda.gov - WHO
www.who.int/en - ACRP
www.acrpnet.org - OHRP - Office for Human Research Protections
www.hhs.gov/ohrp - ICH
www.ich.org - Medwatch
www.fda.gov/medwatch - VICH GL9 (GCP)
www.vichsec.org/en/guidelines/pharmaceuticals/pharma-efficacy/good-clinical-practice - ICH-E6-R2
www.ich.org - Brazil – ANVISA
portal.anvisa.gov.br - Argentina – ANMAT
www.argentina.gob.ar/anmat - Chile – ISP
www.minsal.cl/instituto-de-salud-publica/ - Colombia – INVIMA
www.invima.gov.co - Mexico – COFEPRIS
www.gob.mx/cofepris - Peru – INS
web.ins.gob.pe/
TIPS
FDA Debarred Persons List
www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/fda-debarment-list-drug-product-applications
FDA disqualified/restricted/assurances list for clinical investigators
www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/enforcement-story-archive/court-updates-and-other-enforcement-activities