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LDTs: Congress Set to Scuttle VALID Act at the Eleventh Hour

LDTs: Congress Set to Scuttle VALID Act at the Eleventh Hour

by Glenn S. Demby | Sep 30, 2022 | Essential, Laboratory Industry Report, Legislation-lir

Congress reportedly set to pass a stripped-down version of the FDA user fees bill without the VALID Act component regulating LDTs.

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New FDA Bill Bypasses LDTs Reform—Again 

New FDA Bill Bypasses LDTs Reform—Again 

by Glenn S. Demby | Sep 26, 2022 | News, Open Content

It now appears that Congress is going to dash the lab industry’s hopes yet again by reauthorizing FDA user fees without VALID.

LDTs Legislation Inches Closer to Passage, but Major Hurdles Remain

LDTs Legislation Inches Closer to Passage, but Major Hurdles Remain

by Glenn S. Demby | Aug 11, 2022 | Legislation-nir, News, Open Content

The VALID Act for FDA regulation of laboratory developed tests is working its way through the final stages of the legislative process, but not everyone is loving it.

Revised VALID Act Proposes Risk-Based FDA Regulation of LDTs

Revised VALID Act Proposes Risk-Based FDA Regulation of LDTs

by Glenn S. Demby | Jun 8, 2022 | Articles, Essential, Legislation-nir, National Lab Reporter

The most recent congressional effort to pass LDT legislation may prove to be the one that finally comes to fruition.

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Laboratory Developed Tests: The VALID Act is Back

Laboratory Developed Tests: The VALID Act is Back

by Glenn S. Demby | Mar 18, 2020 | Articles, CLIA-nir, Essential, Laboratory Industry Report, National Lab Reporter, News-nir

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