Public Health Effectiveness of the FDA 510(k) Clearance Process Balancing Patient Safety and Innovation: Workshop Report (2010) / Chapter Skim
Currently Skimming:
Appendix B: Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned Papers
Appendix B: Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned Papers
Pages 67-74
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 67... ...
He has special interests in helping companies to plan development of their drugs on the basis of Food and Drug Administration (FDA) and European Union requirements, prepare for meetings with FDA and its advisory committees, develop risk-management plans, conduct product due-diligence evaluations, and set up process, organization, and staffing plans to achieve their regulatory obligations.
|
From page 68... ...
In 2004, he left FDA to join a regulatory consulting group, NDA Partners, LLP, and resume teaching as a faculty associate at the Sandra Day O'Connor Law School of Arizona State University. In 2006, he joined Élan Pharmaceuticals in South San Francisco as senior vice president for global regulatory and global safety
|
From page 69... ...
Mr. Hutt has served on the IOM Roundtable for the Development of Drugs and Vaccines Against AIDS, the Advisory Committee to the Director of the National Institutes of Health, the NAS Committee on Research Training in the Biomedical and Behavioral Sciences, the National Institutes of Health Advisory Committee to Review the Guidelines for Recombinant DNA Research, the National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS established by the President's Cancer Panel of the National Cancer Institute at the request of President Bush, and five Office of Technology Assessment advisory panels.
|
From page 70... ...
He was a member of the Healthcare Industry Task Force and chaired its Regulatory and Patient Safety Group. On the creation of the Medicines and healthcare Products Regulatory Agency, he acted as joint chief executive until April 2004, when he transferred to become special adviser in advanced health-care technology to the Department of Health and worked on secondment with the European Medicines Agency on benefit–risk evaluation.
|
From page 71... ...
Under his leadership, the office has implemented the medical device reporting regulation for user reporting, has developed a program for reducing the burden on industry for repetitive reporting, and has completed a pilot program to develop a sentinel system for user-facility reporting of adverse events. In addition, he has helped to develop a new program that encourages the application of a wide variety of new statistical methods, with a focus on Bayesian methods, for the device review process.
|
From page 72... ...
He has 28 years of experience in Food and Drug Administration (FDA) regulation of medical devices, having focused on the development and implementation of numerous regulatory strategies regarding the design, manufacture, and marketing of medical devices in the United States.
|
From page 73... ...
Phillips streamlined medical device review processes and launched numerous agency initiatives aimed at enhancing public health while lessening regulatory burden. In addition to serving as the Office of Device Evaluation deputy director for science and regulatory policy, he served as director of program operations, interim director for the Division of General and Restorative Devices, deputy director for the Division of Ophthalmic Devices, and chief of the Diagnostic and Surgical Devices Branch.
|
From page 74... ...
William vaughan is a consultant to Consumers Union on Food and Drug Administration issues. Starting in 1965, he worked for various members of the US House of Representatives Committee on Ways and Means.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.