FDA clears Thermo Scientific 510(k)s for its EliA RNA Pol III and EliA Rib-P tests for aiding in the diagnosis of systemic sclerosis and systemic lupu...
Sidley attorneys say the Justice Department voiced strong support for a fraud-on-FDA theory of liability in a case involving blood glucose meters.
FDA cautions consumers not to use products marketed as mole or skin tag removers.
FDA approves a Foundation Medicine PMA for its FoundationOne CDx to be used as a companion diagnostic for the two approved indications for Genentechs ...
Four additional stakeholders raise concerns about the FDA quality metrics proposal.
FDA releases the FDA-483 with five observations issued following a 2021 inspection at Largo, FL-based BPI Labs.
Some 18 members of Congress ask FDA 19 questions about Covid-19 vaccine safety in children under age 5.
University of Kentucky researchers say FDA should consider moving to an alternate approach to monitoring drug quality rather than relying on current g...