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Posted by Peter on 1-1 2:27 pm
Tags: academic researchers, address scientific and medical advances, CDER, Center for Drug Evaluation and Research, clinical and regulatory principles, Commissioner Scott Gottlieb, DA, development process, disease specialists, evaluate new drugs, guidance documents, integrated across science and regulatory expertise, Janet Woodcock, medical officers, modernize, more tools and support, Office of New Drugs, patient groups, regulatory partners, review process, review staff, role of FDA scientists, safety and efficacy, time with sponsors
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