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FY 2001 ODE Annual Report - Appendix B — ODE Publications

The following is a bibliography of articles and abstracts prepared by the ODE staff and published or presented during FY 2001.

Journals, Newsletter Articles and Book Chapters

Applegate RA, Thibos LN, and Hilmantel G. Optics of Aberroscopy and Super Vision.
J Cataract Refract Surg. 27(7):1093-107, July 2001.

Applegate RA, Hilmantel G, and Thibos LN. Visual Performance Assessment. In Customized Corneal Ablation: The Quest for Supervision. Edited by MacRae SM, Krueger RR, and Applegate RA. SLACK Incorporated, Thorofare, NJ, pp. 81-92, 2001.

Baker KH. Implantable Middle Ear Hearing Devices: A Regulatory Perspective. The Hearing J. 54(8):36-37, August 2001.

Baker KH. Spotlight on Research: Clinical Study and Literature Review of Nasal Irrigation. ORL-Head and Neck Nursing 19(1):14-15, Winter 2001.

Baker KH. How I Do It: Presenting a Poster. ORL-Head and Neck Nursing 19(1):18-19, Winter 2001.

CDC and Expert Consultants Group (Members - Meyers CM, McCool B, Neuland C, and Nutter C). Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients. Morbidity and Mortality Weekly Report 50(RR-5):1-43, April 2001.

Cox AL, Carpenter CF, and Ticehurst JR. Non-A, B, or C Hepatitis. Curr Treatment Options in Infect Dis. 3(5): 449-455, September 2001.

Fourcroy JL. Book Review - Sexual Health for Men by Richard F. Spark. 2000 by Perseus Publishing. In Science Books and Films. Published by American Association for the Advancement of Science (AAAS), 37(2): 63.

Fourcroy JL. Overactive Bladder — A Practical Overview of Diagnosis and Treatment. ADVANCE for Nurse Practitioners 9(3): 59-60, 62, March 2001.

Fourcroy JL. Incontinence in the 21st Century. OB/GYN Special Edition. Spring 2001.

Garnick MB et al. Overview Consensus Statement. Fifth International Conference on Neoadjuvant Hormonal Therapy for Prostate Cancer. Molecular Urology 4(3):89-92, Fall 2000.

Jaffee IS. Implantable Middle Ear Hearing Devices: Food and Drug Administration Review Process. Otolaryngologic Clinics of North America 34(2):515-517, April 2001.

Kammula RG and Morris JM. Considerations for the Biocompatibility Evaluation of Medical Devices. Medical Devices & Diagnostic Industry 82-91, May 2001.

King AJ, Reddy A, Thompson JR, and Rosenthal AR. The Rates of Blindness and of Partial Sight Registration in Glaucoma Patients. EYE 14(Pt 4):613-19, August 2000.

Less JR. The Least Burdensome Provisions of FDAMA. Regulatory Affairs J 8(4):265-267, November 2000.

Lin CS, Fuller J, and Mayhall ES. Federal Regulation of Liquid Chemical Germicides by the U.S. Food and Drug Administration. In Disinfection, Sterilization, and Preservation. Edited by Block SS. Fifth Edition, Lippincott Williams & Wilkins, pp. 1293-1301, 2001.

Mao Q, Ray SC, Laeyendecker O, Ticehurst JR, Strathdee SA, Vlahov D, and Thomas DL. Human Immunodeficiency Virus Seroconversion and Evolution of the Hepatitis C Virus Quasispecies. J Virol 75(7):3259-3267, April 2001.

Meyers CM. Immunopathogenesis of Tubulointerstitial Disease. In Massry & Glassock's Textbook of Nephrology. Edited by Massry SG and Glassock RJ. Lippincott Williams and Wilkins, Baltimore, pp. 639-345, 2001.

Meyers CM. Acute Interstitial Nephritis. In Primer on Kidney Diseases. Edited by Greenberg A, Cheung AK, and National Kidney Foundation. 3rd edition, Academic Press, San Diego, pp. 269-274, 2001.

Moxey-Mims M. Letter to Editor. Comment on "High-Sensitivity C-Reactive Protein: Product Claims and the Food and Drug Administration". Clin Chem 47(9):1743, 2001.

Pollard C, Lytle D, and NIAID. Workshop Summary: Science Evidence on Condom Effectiveness for Sexually Transmitted Disease (STD) Prevention. U.S. Public Health Service, July 20, 2001.

Provost MC and Meyers CM. New Technologies for Patients with End-Stage Renal Disease: the US Regulatory Perspective. In Dialysis, Dialyzers and Sorbents. Edited by Ronco C and Winchester JF. Contributions to Nephrology, Karger Publishers, 133:10-22, 2001.

Sapirstein W et al. Mechanical Cardiac Support 2000: Current Applications and Future Trial Design. June 15-16, 2000 Bethesda, Maryland. J of Am College of Cardiology 37(1): 340-70, January 2001.

Sapirstein W, Zuckerman B, and Dillard J. FDA Approval of Coronary-Artery Brachytherapy. New England J of Med 344(4):297-299, January 25, 2001.

Sapirstein W. Designing Trials for Testing Prosthetic Cardiac Valves: A Food and Drug Administration Perspective. American Heart J 141(5): 861-3, May 2001.

Sapirstein W et al. Conference on Circulatory Support Devices: Database: Relevant or Not. Annals of Thoracic Surg. 71(3 Suppl):S204-9, March 2001.

Sapirstein W, Chandeysson P, and Wentz C. The Food and Drug Administration Approval of Endovascular Grafts for Abdominal Aorta Aneurysm: An 18-Month Retrospective. J Vascular Surg. 34(1):180-3, July 2001.

Sohn MJ, Rho HO, Park MS, Kim JS, and Summers PL. Primary Humoral Immune Response to Formalin Inactivated Hemorrhagic Fever with Renal Syndrome Vaccine (Hantavax): Consideration of Active Immunization in South Korea. Yonsei Med. J 42(3): 278-284, June 2001.

Sorof JM, Urbina EM, Cunningham RJ, Hogg RJ, Moxey-Mims M, Eissa MA, Rolf C and the Ziac Pediatric Hypertension Study Group. Screening for Eligibility in the Study of Antihypertensive Medication in Children: Experience from the Ziacâ Pediatric Hypertension Study. Am J Hypertens 14(8 Pt 1):783-787, August 2001.

Toy J, Bradford RL, and Adler R. Lipid-Mediated Gene Transfection into Chick Embryo Retinal Cells in Ovo and in Vitro. J Neurosci Methods 104(1):1-8, Dec 15, 2000.

Zaremba L. FDA Guidance for Magnetic Resonance System Safety and Patient Exposures: Current Status and Future Considerations. In Magnetic Resonance Procedures: Health Effects and Safety. Edited by Shellock FG. CRC Press, pp. 183-196, 2001.

Abstracts and Presentations

Abel D. Regulatory Environment, Testing and Trials: The Perspective of a Regulator, Endografts 2001 and Beyond Conference, Dublin, Ireland, July 21, 2001.

Carey CC. Variability in Biphasic Waveform Defibrillation Requires Design Validation, FDA Science Forum, Washington, DC, February 15-16, 2001.

Chace NM. FDA Perspective. National Glycohemoglobin Standardization Program Update, Atlanta, GA, January 2001.

Cooper J. FDA Regulation of Workplace and Over the Counter Drug and Alcohol Testing, DATIA 2001 Annual Conference, Phoenix, AZ, June 2, 2001.

Cooper J and Dubois D. How to Present a 510(k), ADVAMED Workshop, Rockville, MD, April 25, 2001.

Demian H. Guidance for Development of the Weight Bearing Devices for THA Joint Repair, Johns Hopkins University School of Medicine, Baltimore, MD, May 11-12, 2001.

Durfor C. The Promise of Tissue Engineering: Regulatory Perspectives, at the 5th International Symposium on Tissue Engineering for Therapeutic Use, Tsukuba, Japan, November 2000.

Durfor C. Multi-Agency Tissue Engineering Science Working Group (MATES) Update on Japanese, MHW & 5th TETU, Rockville, MD, December 2000.

Durfor C. Tissue Engineering: Review of Medical Devices 2001 BECON Reparative Medicine: Growing Tissues and Organs, Bethesda, MD, June 2001.

Echavarria M, Forman M, Schnurr D, Ticehurst J, Bolton S, Enger C, Jabs D, and Charache P. Association of Adenovirus Types 11, 34 and 35 with Parenteral Exposure and Earlier Death in AIDS Patients. Buenos Aires, Argentina: 1st Conference on HIV Pathogenesis and Treatment, 2001.

Forman M, Ray SC, Oberste MS, Modlin JF, Pallansch M, and Ticehurst J. Nucleotide Sequence Differences Among Prototype and Clinical Enteroviruses & Parechoviruses Preserve 5' Non-Translated Region Structure but Can Decrease Negative Predictive Value of Assays That Use Reagent Oligonucleotides. Clearwater Beach FL: 17th Clinical Virology Symposium and Annual Meeting of the Pan American Society for Clinical Virology, Abstract S39, 2001.

Fourcroy JL. The US Anti-doping Agency and Research Priorities at The International Society for Laboratory Hematology, Montpellier, France, April 2001.

Fourcroy JL. Women in Clinical Trials and Female Sexual Function - Development of Drugs. Medical Women's International Association Conference, Sydney, Australia, April 2001.

Fourcroy JL. Diagnostic Tests. The Australia New Zealand Veterans Research Center, Sydney, Australia, April 2001.

Fourcroy JL. Empowerment of the Adolescent Male. The Maryland State Family Planning, Columbia, MD, May 2001.

Fourcroy JL. Doping - Poster Presentation the American Society of Andrology, Montreal, Canada, June 2001.

Fuller J. Antimicrobial Agents and Devices — FDA Regulation. American Bar Association, Special Committee on Pesticides, Chemical Regulation and Right-to-Know, April 27, 2001.

Goode J. FDA Review Issues for Devices with Hemocompatible Coatings. Hemocompatible Workshop, 2001 Surfaces in Biomaterials Foundation Annual Meeting, Scottsdale, AZ, August 29, 2001.

Hackett JL. Pharmacogenetics — FDA and In Vitro Diagnostics. Pharmaceutical Education & Research Institute, Arlington, VA, November 17, 2000.

Hackett JL. FDA and SACGT. Newborn Screening and Genetic Testing Symposium, Raleigh, NC, May 8, 2001.

Hackett JL. Pharmacogenetics: Impact on Drug Development. FDA Oversight of Genetic Testing, Alpha-1 Foundation 3rd International Scientific Conference, Warrenton, VA, June 20, 2001.

Hackett JL. 2001- A Thousand Points of Light of FDA, NCI's Early Detection Research Network Meeting, Washington, DC, June 22, 2001.

Ho C and Kurtzman S. Three Perspectives of Cardiac Electrical Activity, Biomedical Sciences Instrumentation Symposium, Copper Mountain, CO, April 19-23, 2001.

Ho C. Analysis of Water Vapor Content in Ventilator, Biomedical Sciences Instrumentation Symposium, Copper Mountain, CO, April 19-23, 2001.

Horbowyj R and Sauberman H. Commonly Encountered Issues in the Use of Clinical Data to Support a U.S. Marketing Application for a Medical Device. Society of Clinical Trials, Denver, CO, May 2001.

Jevtich M. Perspective from the FDA: FDA Regulation and Experience with Devices for Prostate Cancer. 2nd International Conference on Innovative Solutions for Prostate Cancer Care, San Diego, CA, February 9-11, 2001.

Kammula RG. Use of Consensus Standards and Master Files to Address the Biocompatibility of Medical Devices in the United States. Biocompatibility Workshop, Medical Design and Manufacturing West 2001 Conference, Anaheim, CA, January 7-10, 2001.

Kammula RG. Trained FDA Field Investigators in Conducting Biocompatibility Testing of Medical Devices for Good Laboratory Practices, Non Clinical BioResearch Monitoring Course for FDA Inspectors, Research Triangle Park, NC, August 21, 2001.

Kane J and Durrant JD. Frequency Selectivity: Relationship Between DPOAE Ratio Functions and Psychophysical Tuning Curves in Normally-Hearing Subjects, FDA 2001 Science Forum, Washington, DC, February 15-16, 2001.

Meyers C. FDA Regulation of Medical Devices. World Artificial Organ, Immunology and Transplantation Society, 6th Symposium, Ottawa, Canada, August 2001.

Moxey-Mims M. Update on FDA IRB and Informed Consent Issues. In Vitro Diagnostic Roundtable, Washington, DC, June 2001.

Neuland C. FDA Regulation of Selective Absorptive Apheresis Technologies, 22nd Annual Meeting of the American Society for Apheresis, Niagara Falls, NY, May 18, 2001.

Rechen EJ. Third Party Review of 510(k)s. Medical Design and Manufacturing (MD&M) West Conference, Anaheim, CA, January 2001.

Rechen EJ. Third Party Review of 510(k)s. Medical Design and Manufacturing (MD&M) East Conference, New York City, NY, June 2001.

Rechen EJ. Third Party Review of 510(k)s: Expansion Pilot. AdvaMed's 11th Annual Device Submissions Workshop, Washington, DC, June 2001.

Rechen EJ. FDA's Third Party Review Program. Association of Food and Drug Officials (AFDO) 105th Annual Educational Conference, Atlanta, GA, June 2001.

Robinowitz M. The Bethesda System for Cervical Cytology Nomenclature. NIH Conference, Rockville, MD, May, 2001.

Robinowitz M. FDA Perspective. National Glycohemoglobin Standardization Steering Committee, AACC, Chicago, IL, July 30, 2001.

Rosenthal AR. 4th Seymour Gostin Memorial Lecture at Southwestern Medical Center, University of Texas, Dallas, TX, September 8, 2001.

Sacks W. Medical Uses of Thermography. National Institute of Standards (NIST), Gaithersburg, MD, October 17, 2000.

Sacks W. Emerging Technologies for the Detection and Diagnosis of Breast Cancer. Centers for Disease Control, Atlanta, GA, September 6, 2001.

Sacks W. The Moving Target (Evaluation of Medical Devices in the Face of Ever Advancing Technology and Ever Improving Assessment Methods). Medical Imaging Perception Society Conference, Warrenton, VA, September 21, 2001.

Sapirstein W, Kaczmarek R, and Travis D. Transmyocardial Revascularization. Sex-Specific Utilization, FDA Science Fair, Washington, DC, February 15-16, 2001.

Shulman M. Implementation of the 510(k) Paradigm and Premarket Notification. Medical Design and Manufacturing (MD&M) Minneapolis, MN, October 2000.

Shulman M. Premarket Notification Overview. The Evolution of the 510(k). Medical Design and Manufacturing (MD&M) West Conference, Anaheim, CA, January 2001.

Shulman M. Premarket Notification Regulatory Review. AMDM In Vitro Diagnostics 510(k) Workshop, Rockville, MD, April 2001.

Shulman M. Premarket Notification and FDA CDRH Hot Topics for 2000. Medical Design and Manufacturing (MD&M) East Conference, New York City, NY, June 2001.

Shulman M. 510(k) Submissions 101. AdvaMed, Washington, DC, July 2001.

Sliva CA. CLIA' 88 and Home Use Tests, Regulatory Affairs Professional Society, Washington, DC, July 30-31, 2001.

Sliva CA. Update on Clinical Laboratory Improvement Amendments, American Association for Clinical Chemistry Health Care Forum, Chicago, IL, August 1, 2001.

Ticehurst J. Infectious Diseases Workshop I: Review & Discussion of Draft NCCLS Guideline on Quantitative Methods for Microbiologic Nucleic Acids, 6th Annual Meeting, Association for Molecular Pathology, Denver, CO, November 10, 2000.

Ticehurst J. Use of Rapid Hepatitis and Syphilis Tests in the Public Health Setting, US Centers for Disease Control & Prevention, Atlanta, GA, February 2, 2001.

Ticehurst J. FDA's Role in Pathology, and Why I Come Back to Hopkins: Dept of Pathology Grand Rounds, Johns Hopkins University School of Medicine, Baltimore, MD, February 1, 2001.

Witten C. Hot Topic Forum, ASPS, Los Angeles, CA, October 2000.

Witten C. Roles and Requirements in Planning and Conducting a Clinical Trial. AAOS Washington, DC, December 2000.

Zhou SY, Yue LQ, Ho C, Weininger S, and Gray G. Statistical Issues for Substantial Equivalence Determination of Pulse Oximeters, FDA Science Forum, Washington, DC, February 15-16, 2001.

Staff College Presenters and Faculty

Abel, Dorothy
Allen, Peter
Aziz, Kaiser
Bazaral, Michael
Berman, Michael
Betz, Robert
Boam, Ashley
Brogdon, Nancy
Buckley, Donna
Cooper, Jean
Cygnarowicz, Teresa
DeMarco, Carl
Dillard, James
Eydelman, Malvina
Fuller, Janie
Gatling Jr., Robert
Gonzalea, Gema
Goode, Jennifer
Gutman, Steve
Harvey, Brian
Harvey, Elisa

Hawthorne, Cindy
Kammula, Raja
Kane, James
Karanian, John
Lappalainen, Sharon
Lemperle, Betty
Less, Joanne
Mayhall, Elaine
Melkerson, Mark
Meyers, Catherine
Mitchell, Diane
Morris, Janine
Moynahan, Megan
Neuland, Carolyn
Nguyen, Trinh
Ogden, Neil
Oktay, Hasan
Perticone, Diane
Phillips, Philip
Phillips, Robert
Pluhowski, Nancy

Pollard, Colin
Portnoy, Stuart
Rechen, Eric
Rhodes, Stephen
Robinowitz, Max
Romanell, Lawrence
Rosecrans, Heather
Sacks, William
Saperstein, Wolf
Segerson, David
Shein, Mitchell
Shulman, Marjorie
St. Pierre, Donald
Statland, Bernard
Tillman, Donna-Bea
Ulatowski, Tim
Witten, Celia
Wright, Kathleen
Zuckerman, Bram