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FDA struggles with policy fallout after allowing dozens of Covid-10 serology (antibody) tests to come onto the market without its ...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Technical Considerations for Demonstrating Reliability of E...[ Price : $8.95]
Braun Medical recalls one lot of ceftazidime for injection (2g) and dextrose for injection (50 ml) in its duplex container due to ...[ Price : $8.95]
Top FDA executives outline steps being taken to speed the development of Covid-19 vaccines and therapies.[ Price : $8.95]
FDA warns Tenderneeds Fertility about multiple regulatory violations in its importation and manufacturing of insemination kits and...[ Price : $8.95]
FDA reauthorizes the emergency use of a LabCorp Covid-19 home collection test kit.[ Price : $8.95]
FDA says Kimera Labs should ensure its unapproved exosome products comply with all applicable laws and regulations.[ Price : $8.95]
BakerHostetler attorneys say drug companies need to be particularly sensitive to potential Covid-19 issues in CGMP compliance.