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Federal Register notice: FDA makes available a draft guidance entitled Clinical Drug Interaction Studies With Combined Oral Contraceptives.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.
AstraZeneca says it is preparing an emergency use authorization request for its investigational Covid-19 vaccine AZD1222 after reporting promising pre...
FDA launches its Orphan Drug Designation Portal to support therapy development for rare diseases by enhancing sponsor communication with the agency an...
FDA posts a transcript of its 10/22 Patient Engagement Advisory Committee meeting called to discuss and make recommendations on artificial intelligenc...