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Advanced Medical Technology Association urges FDA to narrow and clarify a draft guidance on quality management system information,...[ Price : $8.95]
Moderna and Merck report updated five-year follow-up data that show their personalized mRNA cancer vaccine candidate, intismeran a...[ Price : $8.95]
FDA warns Temecula, CA-based Prodrome Sciences USA about violations in its conduct of a clinical trial without submitting an IND.[ Price : $8.95]
FDA posts a draft guidance outlining how drug developers can use minimal residual disease and complete response as primary endpoin...[ Price : $8.95]
Novo Nordisk submits to FDA additional studies and analyses it says support its petition asking the agency to act against compound...[ Price : $8.95]
FDA asks Capricor Therapeutics for a full clinical study report from the companys Phase 3 HOPE-3 trial as part of its ongoing BLA ...[ Price : $8.95]
FDA publishes for review and comment the International Council for Harmonization M4Q(R2) guidance establishing the location and st...[ Price : $8.95]
FDA warns Integrity Partners St. Louis, MO-based Chemisphere drug manufacturing facility about CGMP issues in its production of fi...