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Laboratory Developed Tests › Notice of Proposed Rulemaking (NOPR) › Federal Food Drug and Cosmetic Act (FFDCA)

Mintz - Health Care Viewpoints

FDA Faces Critical Deadlines in 2024, Even Without an Election Looming

Mintz - Health Care Viewpoints on

The American public knows that 2024 is a critical election year, with the next race for the presidency in November expected to be another face-off between President Biden and former President Trump. What the majority may not...more

Epstein Becker & Green

What’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New Regulatory...

Epstein Becker & Green on

The Food and Drug Administration (“FDA” or “agency”) intends to issue a notice of proposed rulemaking in August 2023 that will “make explicit” that laboratory developed tests (LDTs) are devices under the federal Food, Drug,...more

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