FDA, NIH Announce Initiative to Fast-Track Medical Innovations to Patients

The U.S. Food and Drug Administration and the National Institutes of Health have announced an initiative designed to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients, according to an FDA news release.

The FDA and NIH will establish a Joint NIH-FDA Leadership Council that will work together to help ensure that regulatory considerations form an integral component of biomedical research planning and that the latest science is integrated into the regulatory review process, according to the release.

The agencies also will jointly issue a Request for Applications, making $6.75 million available over three years for work in regulatory science that should add to the scientific knowledge base by providing new methods, models or technologies that will inform the scientific and regulatory community about better approaches to evaluating safety and efficacy in medical product development, according to the release.

The effort will rely on the NIH's vast experience supporting and facilitating new discoveries in the laboratory and clinic and the FDA's more than 100 years of experience and knowledge in the regulation and approval of drugs, biologics and medical devices, according to the release.

The FDA and the NIH will hold a public meeting in the spring to solicit input on how the agencies can work better together.

Read the release on the FDA-NIH collaboration on medical research.