Senate FDA bill clears committee, would modify regulatory framework for lab developed tests
The Senate Health, Education, Labor & Pensions Committee last night voted 13-9 to advance legislation that would reauthorize Food and Drug Administration user fee programs and modify the regulatory framework for laboratory developed tests. AHA last week urged lawmakers to consider certain changes to the LDT provisions to ensure continued access to these critical tests.
The House last week passed its own bill (H.R. 7667) to reauthorize FDA user fee programs, which does not include the LDT provisions. Among other provisions, the House bill would include drugs on the FDA’s shortages list in a pilot program to designate advanced manufacturing technologies.
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