The National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) have announced plans to establish a Joint NIH-FDA Leadership Council, with the goal of shortening the time it takes to move promising therapies through the regulatory process and into the hands of waiting patients.
The initiative is "good news for people with muscle diseases," said Valerie Cwik, MDA's executive vice president for research and MDA Medical Director. "It will help reduce barriers for new drugs for rare diseases by accelerating the movement of promising discoveries from 'microscope to marketplace.'"
The initiative involves two interrelated scientific disciplines — therapy-focused research and regulatory science — both of which are essential for turning biomedical discoveries into actual therapies.
The Joint NIH-FDA Leadership Council — to be co-chaired by NIH Director Francis Collins and Commissioner of Food and Drugs Margaret Hamburg — will seek to enhance communication between federal regulators and scientists within all phases of therapy development.
In addition, $6.75 million will be made available over three years to support research in regulatory science that will lead to better methods and technologies for evaluating safety and efficacy during drug and therapy development.
The NIH and FDA will hold a public meeting in the spring to solicit input on how the agencies can better work together. To read more, see the NIH-FDA press release.