China’s Food and Drug Administration (CFDA) set a goal to push drugs to clinics faster. How will they accomplish this goal? Recent policy proposals suggest CFDA are looking at the US Food and Drug Administration (FDA) for answers. Imitation is the greatest form of...
In July, China’s Food and Drug Administration (CFDA) allowed self-inspections to occur for imported and local drugs. Although CFDA is allowing self-inspections for drugs, it will also be conducting random on-site inspections upon the reports that companies give them....
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?