Federal Register notice: FDA makes available a draft guidance entitled Technical Considerations for Demonstrating Reliability of Emergency-Use Injecto...
Braun Medical recalls one lot of ceftazidime for injection (2g) and dextrose for injection (50 ml) in its duplex container due to stability issues.
Top FDA executives outline steps being taken to speed the development of Covid-19 vaccines and therapies.
FDA warns Tenderneeds Fertility about multiple regulatory violations in its importation and manufacturing of insemination kits and other items.
FDA reauthorizes the emergency use of a LabCorp Covid-19 home collection test kit.
FDA says Kimera Labs should ensure its unapproved exosome products comply with all applicable laws and regulations.
BakerHostetler attorneys say drug companies need to be particularly sensitive to potential Covid-19 issues in CGMP compliance.
A new study shows that the Trump-touted malaria drug hydroxychloroquine does not reduce the risk of mechanical ventilation in patients hospitalized wi...