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Lab-Developed Test Regs In Spotlight With Citizen Petition, Hamburg Speech

The American Clinical Laboratory Association filed a citizen petition with FDA June 4 reiterating and formalizing its long-held opposition to FDA regulating laboratory-developed test services. The petition closely followed a speech from FDA Commissioner Hamburg emphasizing plans to do just that.

A controversial area of FDA diagnostics regulation gained renewed attention this week with a citizen petition sent to FDA from clinical laboratories and a speech from FDA Commissioner Margaret Hamburg.

The American Clinical Laboratory Association filed its citizen petition with FDA June 4 reiterating and formalizing its long-held opposition to FDA regulation of laboratory-developed tests. ACLA specifically requested...

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