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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...[ Price : $8.95]
FDA co-sponsors a 6/26-27 public workshop on using patient-generated health data in medical device development.[ Price : $8.95]
FDA publishes a draft guidance on the drug development platform technology designation program.[ Price : $8.95]
Federal Register notice: CDER proposes to withdraw approval of four NDAs after the application holders repeatedly failed to file r...