Emphasis placed development of new drugs, biologics
The FDA continues to advance new policies, modernize 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, the agency is discovering more opportunities to intervene in the underlying mechanisms that cause a disease, and potentially arrest and even reverse its progress.
Great effort has been placed into developing technology- and disease-specific regulatory frameworks for innovations that may not have previously had a clear development pathway. The goal is to ensure the development processes are efficient enough to support multiple therapeutic options, not just first-in-class innovations.
Thus far this year, the Center for Drug Evaluation and Research has already approved 45 novel drugs and biologics. This is close to the overall total of 46 in 2017, which was the most approved in more than 20 years.
Two areas of continued focus are the continued modernization of the approach to the design of clinical trials. while making the overall drug development process more efficient and less costly and maintaining regulatory standards. The usage of more sophisticated approaches to learn about the safety and efficacy of treatments can help to reduce the barriers to bringing new science forward and make sure more patients can benefit sooner from improved treatments.