Tag Archives: FDA

FASEB Urges FDA to Resolve Concerns Regarding Proposed Oversight of Laboratory Developed Tests

Laboratory developed tests (LDTs) are in vitro diagnostic tests that are designed, manufactured, and used within a single laboratory and vary widely both in terms of the substances measured and test complexity. Since 1976, the Food and Drug Administration (FDA) has exercised enforcement discretion for LDTs, and primary oversight of such tests has been regulated… Read More »

HHS and NIH Propose to Expand and Enforce Data Reporting Through ClinicalTrials.gov

By Yvette Seger Citing data revealing that 30 percent of a sample of 400 clinical trials had not published or deposited results in the ClinicalTrials.gov database, the National Institutes of Health (NIH) and the U.S. Department of Health and Human Services (HHS) issued separate notices on November 19 announcing plans to enforce the sharing and… Read More »

FDA to Host Workshop on Proposed Framework for Oversight of Laboratory Developed Tests

By Yvette Seger Earlier this fall, the Food and Drug Administration (FDA) released a proposed framework for regulatory oversight of laboratory developed tests (LDTs), a category of in vitro diagnostic devices intended for clinical use and designed, manufactured, and used within a single laboratory. Intended to reflect the changing landscape for the development and clinical… Read More »