FDA Clarifies Postmarket Filings in Accordance with ICH Standards
The FDA wants to see both efficacy and effectiveness data in future postmarket filings to better conform to International Conference on Harmonization standards.
A final guidance bemoaning the lack of standardization between the U.S., Europe and Japan in postmarket submissions makes a point of distinguishing clinical efficacy data from medical practice efficacy data. The document pushes for both when companies submit periodic benefit/risk evaluation reports.
This change is intended to unify regulatory standards among those regions, some of which may interpret data efficacy or effectiveness as being exclusively clinical or medical.