Devices & Diagnostics Letter
Feb. 20, 2012
| Vol.
39 No.
8
Lawmakers Question FDA, NIH on Enforcement of AE Reporting
Three House Democrats are questioning whether the FDA and NIH are adequately enforcing a law that requires online reporting of clinical trial data — a key part of the 2007 FDA Amendments Act (FDAAA) that was spurred by reporting failures that kept dangerous or ineffective drugs on the market.
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