2010-02-24
On February 23rd, NIH Director Dr. Francis Collins,
FDA Commissioner Dr. Margaret Hamburg, and Secretary of Health and
Human Services Kathleen Sebelius announced an initiative designed expedite to
the process to get scientific breakthroughs to patients.
The initiative involves two interrelated scientific
disciplines vital in turning biomedical discoveries into products that can help
patients fighting diseases like cancer:
- Translational Science: the shaping of basic scientific
discoveries into treatments
- Regulatory Science: the development and use of new
tools, standards and approaches to more efficiently develop products and to
more effectively evaluate product safety, efficacy and quality.
As part of the effort, the agencies will establish a joint NIH-FDA
Leadership Council to spearhead collaborative work on important public
health issues. The council 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.
In addition, the NIH and the FDA will jointly issue a RFA,
making $6.75 million dollars available over three years for work on regulatory
science. The research supported through this initiative aims to add
to the scientific base by providing new methods, models and technologies that
will inform the scientific community about better approaches to evaluating
safety and efficacy of medical product development.
This new initiative will rely on the NIH's
expertise in supporting and facilitating new discoveries in the lab, and
the FDA's experience and knowledge in the regulation and approval of drugs,
biologics and devices.
The FDA and the NIH will hold a public meeting in the
spring to solicit input on how the agencies can collaborate more efficiently.
Additional
information:
NIH
press-release: http://www.nih.gov/news/health/feb2010/od-24.htm
Regulatory
Science at FDA:
http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/default.htm
