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The agency is developing technology- and disease-specific regulatory frameworks for innovations that may not have previously had a clear development pathway.
FDA Commissioner Scott Gottlieb announced on October 15, 2018 that the agency is developing technology- and disease-specific regulatory frameworks for innovations that may not have previously had a clear development pathway. This effort is spurred by the advancement of new therapies in development, such as cell and gene therapies and targeted therapies. The agency wants to ensure that development processes can support multiple therapeutic options and that competition within drug classes is promoted.
The agency will be focusing on its approach to design of clinical trials and making the drug development process more efficient and less costly. A new pilot program has been designed to encourage the use of complex innovative trial designs. In addition, two new guidance documents have been published to provide clarity on next-generation therapies.
“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,” Gottlieb stated in a press release.