Regulatory Sciences
Regulatory science is the science of creating new tools, standards, and methodologies to evaluate the safety, toxicity, and efficacy of all FDA-regulated products, as well as their quality and performance. An method to building regulatory science programmes that builds on what has been learned in developing training programmes for translational scientists, and this model for regulatory science programme development is being refined and adopted by all of the CTSA network's institutions. The target audience for such a programme is broad, and it is vital to break free from the belief that regulatory science is solely under the control of FDA, and that the field's responsibility is to train a workforce that will work within FDA's constraints.