The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong enough to make certain that regulatory decisions are based on the best scientific evidence. The IOM held a public workshop on February 26, 2010, to examine the state of regulatory science and to consider approaches for enhancing it.
1 Front Matter; 2 1 Introduction; 3 2 Defining Regulatory Science; 4 3 The Urgent Need for Regulatory Science; 5 4 Barriers to Enhanced Regulatory Science; 6 5 Potential Models for Building a Regulatory Science Infrastructure; 7 6 Challenges in Engaging the Public Policy Community; 8 7 Envisioning Successful Regulatory Science at FDA; 9 8 Considering Next Steps; 10 References; 11 Appendix A: Agenda; 12 Appendix B: Participant Biographies
Number Of Pages: 94
Published: 15th February 2011
Publisher: National Academies Press
Country of Publication: US
Dimensions (cm): 22.9 x 15.2
Weight (kg): 0.16