INDs Needed For Some Comparative Effectiveness Research, FDA Suggests
Executive Summary
Investigational new drug applications should be sought for some types of comparative effectiveness research of marketed pharmaceuticals, even when not conducted by the manufacturer, FDA suggests in a new draft guidance.
You may also be interested in...
FDA Guidance Could Impose Drug-Like Burden On Cosmetic Trials
An FDA guidance document intended to clarify if firms conducting certain drug studies involving human subjects are obligated to file Investigational New Drug Applications instead raises questions for the cosmetics industry.