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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.

CDC, Major Laboratory Companies Launch New Tests for Monkeypox

CDC, Major Laboratory Companies Launch New Tests for Monkeypox

by Glenn S. Demby | Jul 19, 2022 | News, Open Content

As the outbreak continues to grow in countries that have not historically seen monkeypox cases, testing companies are stepping up.

Bill to Regulate LDTs Advances, but Is No Slam Dunk for Final Passage

Bill to Regulate LDTs Advances, but Is No Slam Dunk for Final Passage

by Glenn S. Demby | Jun 29, 2022 | Essential, FDA-lir, Laboratory Industry Report

Now that the finishing touches have been put on LDT-related legislation, what is the likelihood that it will pass?

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Laboratory Developed Test Regulatory Reform Moves Closer to Reality

Laboratory Developed Test Regulatory Reform Moves Closer to Reality

by Glenn S. Demby | Jun 15, 2022 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Legislation-dtet

Newly proposed legislation would establish a risk-based regulatory system for LDT regulation, though not everyone is happy with it.

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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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