The new commissioner for the U.S. Food and Drug Administration (FDA) provided an update on his goals for altering the agency’s approach to approving new drugs and medical devices.
In a blog post, Scott Gottlieb, M.D., announced the FDA would soon unveil a project called the Innovation Initiative.
The initiative will be geared towards updating standard regulatory processes to ensure they are, “modern and efficient, so that safe and effective new technologies can reach patients in a timely manner,” per the announcement.
Implementing these new programs will fall under the framework of the 21st Century Cures Act, which was passed at the tail end of the Obama Administration and granted the FDA new funding of over $500 million within the next 9 years.
One of the notable endeavors Gottlieb highlighted is the use of computer models and simulations to help develop and evaluate devices and drugs.
“Modeling and simulation play a critical role in organizing diverse data sets and exploring alternate study designs. This enables safe and effective new therapeutics to advance more efficiently through the different stages of clinical trials. FDA’s efforts in modeling and simulation are enabled through multiple collaborations with external parties that provide additional expertise and infrastructure to advance the development of these state-of-the-art technologies,” wrote Gottlieb.
The agency’s Center for Drug Evaluation and Research is currently using these novel tools for functions like predicting clinical outcomes, inform designs for clinical trials, optimize dosing regimens, and more.
Other projects the FDA is taking in concordance with the legislation include a new designation for Regenerative Medicine Advanced Therapies from the Center for Biologics Evaluation and Research. This label is available for certain cell therapies and therapeutic tissue engineering products as well as other types of combination products. Essentially, this serves as a new designation to enable access to the FDA’s existing expedited programs with the reveal of a comprehensive framework for regenerative medicine arriving in September.
Another program launched under the Cures Act is the Oncology Center of Excellence. This institution is the first inter-center institute at the FDA focusing on a specific disease area instead of a specific product. The institute will coordinate the clinical review of cancer treatments across the drug, device, and biologic centers.
Gottlieb has hit the ground running since he was officially confirmed to the role in April. He vowed during his hearings that, “science will prevail at the agency.”
He also recently launched a new suite of tools aimed at eliminating the FDA’s existing orphan designation request backlog so his team can guarantee timely response to all new requests for designation.
Filed Under: Drug Discovery