The FDA has a program, called The Critical Path to New Medical Products, that will modernize the processes used to take products from “proof of concept” to a released and approved product. The latest step in this project is to identify specific areas or opportunities where improvements can be made (story here).
gap between the quick pace of new biomedical discoveries and the slower
pace at which those discoveries are currently developed into therapies.
The release of the list marks a starting point in identifying
priorities to be accomplished under the Critical Path Initiative.
Government, industry and academic experts estimate that, if
accomplished, the new tests and tools developed under the Critical Path
Initiative will modernize the drug development process by 2010 and help
to get new medical discoveries to patients faster and at a lower cost.
The Critical Path Opportunities Report is organized into six broad
topic areas: development of biomarkers; clinical trial designs,
bioinformatics, manufacturing, public health needs and pediatrics.
FDA's outreach efforts uncovered a consensus that the two most
important areas for improving medical product development are biomarker
development (Topic 1 ) and streamlining clinical trials (Topic 2).
Note that bioinformatics is third on the list. As software becomes more tightly integrated into the diagnosis and care of patients, regulatory focus is expected to increase. The configuration, implementation and use of clinical software is what's getting most of the prospective regulatory focus currently, but I would not rule out the eventual application of the Quality System regulation (QSR) to software development.