Tuesday, 18 December 2018

FDA’s new steps to modernize drug development

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.

The scientific opportunities we’re seeing today demand that we make sure our policies are as sophisticated as the treatments that are being developed. As the nature of drug discovery and development has become more focused on basic mechanisms of disease, targeted at specific genetic or molecular dysfunctions, science is bringing forward more novel opportunities to meaningfully address human disease.

In response, we’re developing technology- and disease-specific regulatory frameworks for innovations that may not have previously had a clear development pathway. We also want to ensure that the development processes are efficient enough to support multiple therapeutic options, not just first-in-class innovations. We need to facilitate second-and-third-to-market innovation as a way to promote more competition within drug classes. This competition can offer important therapeutic differentiation along with opportunities for price competition that can lower costs and broaden patient access.

For further details, see FDA - https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm623411.htm

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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