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Date Issued
Submitting OIG
Department of Health & Human Services OIG
Other Participating OIGs
Department of Health & Human Services OIG
Agencies Reviewed/Investigated
Department of Health & Human Services
Components
Food and Drug Administration
Report Number
OEI-01-17-00510
Report Type
Inspection / Evaluation
Agency Wide
Yes
Number of Recommendations
4
Questioned Costs
$0
Funds for Better Use
$0

Open Recommendations

This report has 4 open recommendations.
Recommendation Number Significant Recommendation Recommended Questioned Costs Recommended Funds for Better Use Additional Details
6602 No $0 $0

FDA should use the new TIRF REMS patient registry to monitor for known areas of risk, such as inappropriate conversions and off-label prescribing.

6603 No $0 $0

FDA should strengthen the REMS for opioid analgesics (the successor to ER/LA opioids) by requiring prescriber training.

6604 No $0 $0

FDA should enhance its REMS assessment review process.

6605 No $0 $0

FDA should seek additional authority to ensure that manufacturers are held accountable when appropriate.

Department of Health & Human Services OIG

United States