FDA to release new regenerative medicine framework in September

Written by Freya Leask

In a blog post, FDA Commissioner Scott Gottlieb outlined how the agency plans to implement the 21st Century Cures Act with sufficient “regulatory oversight”.

In a recent blog post, FDA Commissioner Scott Gottlieb cast more light over how the FDA will implement the 21st Century Cures Act, passed in 2016 under Barack Obama and gave the FDA “many new authorities and resources to accomplish this mission”. In the post, Gottlieb laid out a work plan with detailed examples of how technology and investment will advance research and expedite potential therapies.

A clear example of where some of this funding will be applied was in developing computer models and simulations to evaluate potential drugs and devices.

“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,” Gottlieb explained.

“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.”

Gottlieb also highlighted the work that Center for Biologics Evaluation and Research (CBER) is already carrying out. The CBER is already utilizing in silico techniques to predict clinical outcomes and product safety, inform clinical trial designs, and optimize dosing, and is also implementing the Regenerative Medicine Advanced Therapy (RMAT) designation which provides resources to expedite promising regenerative medicines that address unmet needs.

“We’ve already received almost two dozen requests for RMAT designation and granted four such designations to date,” Gottlieb revealed.

“To continue to advance these opportunities, we’ll be announcing this September a comprehensive framework for the development and proper FDA oversight of regenerative medicine. This new policy effort will comprise a series of new guidance documents covering many aspects of the regulation of regenerative medicine products.”

Read the full blog post