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FDA posts a draft guidance entitled Mpox: Development of Drugs and Biological Products.[ Price : $8.95]
FDA asks a Florida federal court for an injunction against LGM Pharma to ensure that it no longer holds and ships adulterated drug...[ Price : $8.95]
FDA releases the form FDA-483 with 11 observations from an inspection at Indias Intas Pharmaceuticals.[ Price : $8.95]
FDA clears a Realize Medical 510(k) for its Elucis virtual reality software for surgical planning.[ Price : $8.95]
FDA commissioner Robert Califf says FDA has a key role to play in reshaping the nations system for generating medical evidence to ...[ Price : $8.95]
FDA sends Eli Lilly a complete response letter for its accelerated approval BLA submission for donanemab, indicated for treating e...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled Adverse Event Program for Medical Devi...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Protection of Human Subjects; Informed Cons...