Pillar II, Highlights, 2012

Central to MCMi is the science that underpins virtually every regulatory decision FDA makes. Through the MCMi regulatory science program, FDA is helping build the innovative scientific tools we need, like new models that can accurately reflect human response, to help make sure the drugs, vaccines, and medical devices being developed are safe and effective.  In addition to collaborative research projects with our Federal partners, FDA is sponsoring and co-sponsoring public workshops and scientific meetings to explore critical topics related to MCM development and approval.  In early June, we will be highlighting many of the MCM regulatory science projects we are conducting at a 2-day public workshop.

• MCMi awards Regulatory Science grant to Stanford University
• September 17-18, 2012: Workshop on Developing Animal Models. Registration and workshop information now available.
• September 6-7, 2012: Workshop on Risks and Benefits of Hydroxyethyl Starch Solutions
• August 23, 2012: Public Workshop on Use of Influenza Disease Models for Benefit-Risk Evaluation of Vaccines
• July 24 workshop: Use of Computer Simulation of the US Blood Supply in Support of Planning for Emergency Preparedness and Medical Countermeasures
• June 19-20, 2012: NIAID/FDA Universal Influenza Vaccines Meeting, Register  now
• June 5 & 6 MCMi REGULATORY SCIENCE SYMPOSIUM at White Oak, Silver Spring, MD; posters and presentations on regulatory science program to support development and approval of medical countermeasures. See Federal Register notice.
• April 2 and April 3-4 Advisory Committee meetings (i.e., Anti-Infective Drugs and Nonprescription Drugs)

• February 2012 MCM Workshop on Ethical and Regulatory Challenges in Development of Medical Countermeasures for Pediactrics