Ethics and the marketing authorization of pharmaceuticals: what happens to ethical issues discovered post-trial and pre-marketing authorization?

Table 3 Highlights

	N
Inspected marketing authorization applications with ethically relevant findings	37
Inspections with the conclusion that the inspected sites were generally GCP compliant	30
Ethically relevant findings discussed in Day 150 joint response assessment reports or Day 180 list of outstanding issues	0

ISSN: 1472-6939