FDA extends from 24 to 36 months the expiration date for 42 lots of Cutaquig if they are stored at a cooler temperature.
FDA clears a Neuronetics 510(k) for its TouchStar treatment, a three-minute intermittent theta burst protocol for use with its NeuroStar Advanced Ther...
FDA recognizes the ANSI board as an accreditation body for the agencys Accreditation Scheme for Conformity Assessment pilot project.
FDA releases its latest batch of Warning Letters that includes one medical product company AuroLife Pharma.
Three Covington & Burling attorneys identify five areas of FDA work where the Biden administration may exercise priorities.
Federal Register notice: FDA makes available a draft guidance entitled Clinical Drug Interaction Studies With Combined Oral Contraceptives.
Federal Register notice: FDA makes available a final guidance on elemental impurities in animal drug products.
HHS moves to terminate FDAs unapproved drug initiative as part of Trump administration efforts to reduce prescription drug costs.