FY 2003 ODE/OIVD Annual Report - Appendix C- OIVD Publications

Journals, Newsletter Articles and Book Chapters

Gutman S, Bernhardt P, Pinkos A, Moxey-Mims M, Knott T, and Cooper J. Regulatory Aspects of Invasive Glucose Measurements. Diabetes Technology & Therapeutics 4(6):775-777, 2002.

Gutman S, Bernhardt P, Pinkos A, Moxey-Mims M, Knott T, and Cooper J. Regulatory Aspects of Non-Invasive Glucose Measurements. Diabetes Technology & Therapeutics 4(6):779-781, 2002.

Lesko LJ, Salerno RA, Spear BB, Anderson DC, Anderson T, Brazell C, Collins J, Dorner A, Essayan D, Gomez-Mancilla B, Hackett J, Huang S-M, Ide S, Killinger J, Leighton J, Mansfield E, Meyer R, Ryan SG, Schmith V, Shaw P, Sistare F, Watson M, and Worobec A. Pharmacogenetics and Pharmacogenomics in Drug Development and Regulatory Decision-Making: Report of the First FDA-PWG-PhRMA-DruSafe Workshop. J. Clin. Pharmacol. 43:342-358, 2003.

Mansfield E. Genetic Testing and Personalized Medicine: An FDA View. Preclinica 1(4):155-158, 2003.

Schoonmaker M, Bagley G, and Scanlan M. Coordination of Federal Regulation and Payment for New Diagnostic Tests: A Proposed New Approach. Food and Drug Law Journal 57(2):195-204, 2002.

Schoonmaker M. The Third Party Payer System and Coverage Decision-Making and (Chapt 7) Payment Policy, Billing Practice and Specialty Issues. In Manual on Reimbursement for Medical Genetics Services. Edited by M.S. Williams. American College of Medical Genetics, Rockville, MD, 2002.

Abstracts and Presentations

Altaie S, Bautista J, Benson C, Callaghan J, Chesler R, Cooper J, Poole F, Shively R, and St. Pierre D. All You Want to Know About 510(k) Submissions for IVDs. Association of Medical Diagnostics Manufacturers 510(k) Workshop, Rockville, MD, April 22, 2003.

Bernhardt P. FDA Oversight of New Glucose Diagnostic Devices. The Second La Jolla Conference on Glucose Monitoring and Control, La Jolla, CA, February 13 -17, 2003.

Callaghan J. Software Requirements for Part 11 and an Overview of Software Guidance Documents. The Regulatory Affairs Professionals Society meeting, San Francisco, CA, November 4-5, 2002.

Chan M. The Impact of Standards on Determining the Approvability of Multiplexed RNA-based In Vitro Diagnostic Tests. NIST sponsored workshop on "Metrology and Standards Needs for Gene Expression Technologies: Universal RNA Standards", Palo Alto, CA, March 27-30, 2003.

Chan M. Genomics-based Diagnostics - FDA Perspectives. MD Anderson Cancer Center sponsored Cancer Therapeutics Discovery Program Workshop on "Designing integrated clinical trials for "response-marker" discovery with novel biologically targeted agents", Houston, TX, April 25-26, 2003.

Chan M. The Role of FDA in the Regulation of in vitro Diagnostics. The Fourth Principal Investigator's Meeting of the Innovative Molecular Analysis Technologies Program, San Diego, CA, June 6-18, 2003.

Ellis C. Women and Cardiovascular Disease. FDA Women's Equality Day Educational Seminar, Jamaica, NY, August 4, 2003.

Magruder L. Determine Daily Workload Limits for Cytotechnologists Using New Technologies that Locate and Mark the Location of Abnormal Cells on a Pap Slide. Cytopathology Education and Technology Consortium (CETC), Salt Lake City, UT, November 7, 2002.

Mansfield E and Schoonmaker M. Points to Consider in Microarray Test Development. Association of Medical Device Manufacturers, Rockville, MD, April 24, 2003.

Poole F. Malaria Microscopy - Issues in Clinical Trials. American Society for Tropical Medicine & Hygiene Conference, Denver, CO, November 11-13, 2002.

Poole F. FDA Perspectives on Using Commercial NAAT Kits. Association of Public Health Laboratories Conference, Denver, CO, March 5-7, 2003.

Robinowitz M. FDA Regulation of Tumor Marker In Vitro Diagnostic Tests. C-Kit Standardization Expert Panel. College of American Pathologists Meeting, Washington, DC, February 5, 2003.

Sauberman H, Cooper J, Bernhardt P, and Pinkos A. Regulatory Considerations for Invasive and Non-Invasive Glucose Measurement Devices. Abstract, 9th Annual FDA Science Forum, Rockville, MD, 2003.

Sheldon A, Altaie S, Marsik F, Silver H, and Unowsky J. Guidance for Industry Document-Development, Analysis, and Presentation of Microbiological Data for Antibacterial Drug Products. Abstract X-05, p.199, 9th Annual FDA Science Forum, Rockville, MD, 2003.

Shively R. Poxvirus and Other Febrile Vesicular Rash Illness Diagnostic Testing. The National Center for Infectious Diseases (NCID) of the Centers for Disease Control and Prevention (CDC), in collaboration with the Association of Public Health Laboratories, and the American Society for Microbiology Symposium, San Diego, CA, October 1, 2002.

Shively R. Molecular Methods: Impact on Public Health Practice. Association of Public Health Laboratories Conference, Denver, CO, March 5-7, 2003.

Shively R. Overcoming Regulatory Hurdles. American Society of Microbiology Conference, Baltimore, MD, March 9, 2003.

Wright DK. How Decision Making Drives Viral Testing. Clinical Virology Symposium Annual Meeting of the Pan America Society for Clinical Virology, Clearwater, FL, April 27-30, 2003.

Staff College Presenters and Faculty