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Federal Register notice: FDA seeks comments on an OMB information collection extension entitled De Novo Classification Process (Ev...[ Price : $8.95]
Federal Register notice: FDA announces the issuance of an emergency use authorization for Invivyds Pemgarda (pemivibart) for use a...[ Price : $8.95]
FDA warns Chinas Ostar Beauty Sci-Tech about illegally marketing unapproved medical devices.[ Price : $8.95]
FDA warns Charlottesville, VA-based ION Intelligence of Nature about multiple violations in its production of drugs and dietary su...[ Price : $8.95]
FDA clears a Spineart 510(k) for its Scarlet AC-Ti secured anterior cervical cage.[ Price : $8.95]
Teva says FDA should drop its recommendation for the use of dedicated manufacturing facilities for ezetimibe to prevent cross-cont...[ Price : $8.95]
FDA publishes for comment the International Council for Harmonization M14 guidance on general principles for planning, designing, ...[ Price : $8.95]
FDA accepts for priority review a Sanofi supplemental BLA for Sarclisa (isatuximab) in combination with standard of care for treat...