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FDA publishes a draft guidance on the required electronic format for submission of over-the-counter monographs.[ Price : $8.95]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.[ Price : $8.95]
Federal Register notice: CBERs Office of Tissues and Advanced Therapies has modified its organizational structures to redesignate ...[ Price : $8.95]
CDER Office of Clinical Pharmacology researchers outline the value of leveraging clinical pharmacology principles during drug deve...[ Price : $8.95]
Rep. A Donald McEachin introduces legislation to allow generic drug manufacturers to independently add safety-related information ...