martes, 16 de octubre de 2018

Press Announcements > Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies

Press Announcements > Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies









The FDA continues to advance new policies, modernize our programs and advance opportunities for developing more targeted therapies. Using new technology platforms such as cell and gene therapies and small molecule drugs that target the genomic basis of disease, there are more opportunities to intervene in the underlying mechanisms that cause a disease, and potentially arrest and even reverse its progress. Our efforts are aimed at making sure that our regulatory framework is adapted to these challenges and opportunities, allows for the efficient development of these innovations and the robust demonstration of their safety and efficacy. Our comprehensive efforts are aimed at improving every stage of drug development. We’re focused on making the process of generating pre-clinical and clinical evidence required for making risk-based regulatory decisions more modern, more scientifically rigorous, and more efficient.

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