Pillar II Highlights, 2011

FDA has made a significant investment to enhance its regulatory science program for MCMs.  A Steering Committee comprising FDA experts and Enterprise partners peer reviewed FDA’s intramural MCMi Regulatory Science research proposals to ensure their alignment with Enterprise priorities. More than 80 intramural research projects were identified for funding. 

Encouraging the development and qualification of animal models to support MCM development is a top priority. The MCMi is supporting a program to qualify animal models, which will enable a product-neutral evaluation and qualification of animal models for specific contexts of use. This project complements animal model development programs at the National Institutes of Health (NIH) and the US Biomedical Advanced Research and Development Authority (BARDA) located in HHS's ASPR. FDA is also in the process of revising its draft guidance on “Essential Elements to Address Efficacy Under the Animal Rule¹,” following a fall 2010 public workshop.

FDA has established a memorandum of understanding with the DoD’s Defense Advanced Research Projects Agency (DARPA). FDA and DARPA will be collaborating on regulatory science research in support of innovative regulatory tools, such as biomimetic models, that can be used in development and approval of MCMs.