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Challenges to FDA's Ability To Monitor and Inspect Foreign Clinical Trials

Issued on  | Posted on  | Report number: OEI-01-08-00510

Report Materials

10-E-01-040.01 to FDA - Closed Implemented
Closed on 04/05/2022
FDA should require standardized electronic clinical trial data and create an internal database.

View in Recommendation Tracker
Report Type
Evaluation
HHS Agencies
Food and Drug Administration
Issue Areas
Food, Drug and Device Safety Public Health Issues
Target Groups
-
Financial Groups
Other Funding

Notice

This report may be subject to section 5274 of the National Defense Authorization Act Fiscal Year 2023, 117 Pub. L. 263.