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Labs and Industry Stakeholders Respond to FDA LDT Rule

Explore the response to the FDA's Laboratory Developed Tests, LDTs, final rule, including industry concessions, legal challenges, and legislative reactions. ....

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New FDA Reform Legislation: Congress Gifts A

On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023 (H.R. 2617), an omnibus appropriations bill to fund the U.S. government for fiscal year 2023. ....

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FDA Regulation of LDTs Inches Closer with VALID Act

The VALID Act would impose requirements and authorities governing premarket review of LDTs, registration, and listing of LDTs, LDT design and quality, labeling, adverse events, and corrections and removals, as well as postmarket surveillance obligations ....

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FDA Regulation of LDTs Inches Closer with VALID Act

FDA Regulation of LDTs Inches Closer with VALID Act
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And So It Begins: House Energy and Commerce Leaders Unveil FDA User Fees Legislative Package | King & Spalding

On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user. ....

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