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FDA publishes a guidance on 510(k) submissions for computer-assisted detection devices applied to radiology images and device data...[ Price : $8.95]
FDA issues a revised final guidance entitled Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devic...[ Price : $8.95]
FDA releases the form FDA-483 with five observations from an inspection at the Ripley, MS-based Delta Pharma outsourcing facility.[ Price : $8.95]
FDA publishes a draft guidance on the required electronic format for submission of over-the-counter monographs.[ Price : $8.95]
FDA updates its Covid-19 test policy to send more tests through the traditional review pathways and away from emergency use author...[ Price : $8.95]
Federal Register notice: FDA modifies the organizational structure of the Office of Regulatory Affairs and field offices.[ Price : $8.95]
FDA publishes a guidance explaining the scope of its oversight of clinical decision support software in light of changes mandated ...[ Price : $8.95]
FDA warns Chinas Zhejiang Tianyu Pharmaceutical Co. about CGMP deviations in the production of active pharmaceutical ingredients.