Will the FDA accept clinical data generated in Venezuela? Foreign clinical data is eligible for FDA submission and review under 21 CFR 812.28 when the investigation meets the good-clinical-practice conditions in that rule — including ethics-committee oversight and informed consent. bioaccess® designs every Venezuela study with that FDA conversation in mind: electronic data capture, structured adverse-event reporting, and source data verification, at ISO 14155 discipline. Eligibility is not a guarantee of clearance or approval.
Foreign clinical data — including data generated in Venezuela under INHRR authorization — is eligible for FDA submission and review when the investigation complies with good clinical practice as 21 CFR 812.28 defines it. The rule's conditions include independent ethics-committee oversight and informed consent obtained in accordance with FDA requirements. That is the legal frame. Everything on this page sits inside it.