FDA Inspections

/FDA Inspections
2 07, 2018

Nontransferable Obligations: Why Sponsors Fail Inspections

2018-07-02T11:18:16+00:00

Part 1: Lack of Oversight Discussion of FDA inspections, whether for cause or part of a routine GCP inspection, usually centers on the inspection of trial sites and the CROs who are tasked with managing them. The reason for the disproportionate focus on the inspection of trial sites and CROs stems from two material [...]

Nontransferable Obligations: Why Sponsors Fail Inspections2018-07-02T11:18:16+00:00