[ Price : $8.95]
FDA says it will start accepting applications on 2/1 for its new PreCheck Pilot program intended to boost domestic drug manufactur...[ Price : $8.95]
Four drug industry stakeholders say they support an FDA draft guidance proposing to reduce reliance on comparative efficacy studie...[ Price : $8.95]
FDA says its new ImportShield program improved processing speed and volume capacity while reducing staff hours in its first four m...[ Price : $8.95]
Advanced Medical Technology Association urges FDA to narrow and clarify a draft guidance on quality management system information,...[ Price : $8.95]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FDA posts a draft guidance outlining how drug developers can use minimal residual disease and complete response as primary endpoin...[ Price : $8.95]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]
Moderna and Merck report updated five-year follow-up data that show their personalized mRNA cancer vaccine candidate, intismeran a...