Federal Register notice: FDA submits to OMB an information collection extension entitled Tropical Disease Priority Review Vouchers.
GSK announces positive data from a pre-specified efficacy interim analysis of its AReSVi 006 Phase 3 trial evaluating the companys respiratory syncyti...
An FDA January inspection at Bioiberica (Barcelona, Spain) leads to a five-item Form FDA-483 that cited significant GMP violations at the drug substan...
CBER updates its prioritization schedule for the remainder of 2022 to account for Covid-19-related work, while it plans to return to normal operating ...
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 ...