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.
Institute of Medicine. 2011. Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary. Washington, DC: The National Academies Press. https://doi.org/10.17226/12968.
|2 Defining Regulatory Science||5-12|
|3 The Urgent Need for Regulatory Science||13-22|
|4 Barriers to Enhanced Regulatory Science||23-30|
|5 Potential Models for Building a Regulatory Science Infrastructure||31-38|
|6 Challenges in Engaging the Public Policy Community||39-44|
|7 Envisioning Successful Regulatory Science at FDA||45-48|
|8 Considering Next Steps||49-52|
|Appendix A: Agenda||57-60|
|Appendix B: Participant Biographies||61-78|
The Chapter Skim search tool presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter. You may select key terms to highlight them within pages of each chapter.
The National Academies Press (NAP) has partnered with Copyright Clearance Center's Rightslink service to offer you a variety of options for reusing NAP content. Through Rightslink, you may request permission to reprint NAP content in another publication, course pack, secure website, or other media. Rightslink allows you to instantly obtain permission, pay related fees, and print a license directly from the NAP website. The complete terms and conditions of your reuse license can be found in the license agreement that will be made available to you during the online order process. To request permission through Rightslink you are required to create an account by filling out a simple online form. The following list describes license reuses offered by the National Academies Press (NAP) through Rightslink:
Click here to obtain permission for the above reuses. If you have questions or comments concerning the Rightslink service, please contact:
Rightslink Customer Care
Tel (toll free): 877/622-5543
To request permission to distribute a PDF, please contact our Customer Service Department at 800-624-6242 for pricing.
To request permission to translate a book published by the National Academies Press or its imprint, the Joseph Henry Press, pleaseclick here to view more information.