FY 2000 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 2000.
Journals, Newsletter Articles and Book Chapters
Atwood CS, Hovey RC, Glover JP, Chepko G, Ginsburg E, Robison WG Jr. and Vonderhaar BK. Progesterone Induces Side Branching of the Ductal Epithelium in the Mammary Glands of Peripubertal Mice. J. Endocrinol. 167(1): 39-52, 2000.
Banu N, Mozes MM, Kopp JB, Ziyadeh FN, and Meyers CM. Regulation of Inducible Class II MHC, Costimulatory Molecules, and Cytokine Expression in TGF-1 Knock-Out Renal Epithelial Cells. Effects of Exogenous TGF-beta1. Journal of the American Society of Nephrology 10:507a, 1999.
Carey CC and Callahan TJ. Automated External Defibrillators in Children: Food and Drug Administration Issues. In Ventricular Fibrillation: A Pediatric Problem, edited by Linda Quan and Wayne H. Franklin, Armonk, NY: Futura Publishing Company, Inc., pp 195-208, 2000.
Carpenter CF and Ticehurst JR. Non-A, Non-B, or Non-C Hepatitis. Current Treatment Options in Infectious Diseases 2(5):423-429, 2000.
Chenault VM and Benson CC. Regulatory Aspects of Lipid and Lipoprotein Measurements. In Handbook of Lipoprotein Testing, 2nd Edition, edited by Nader Rafai, G. Russell Warnick and Marek H. Dominiczak, American Association for Clinical Chemistry Press, pp 767-794, 2000.
Cornelius MJ. FDA Guidelines for Endoscope Reprocessing. Gastrointestinal Endoscopy Clinics of North America 10(2):259-264, 2000.
Glover JP, Jacot JL, Basso MD, Hohman TC, and Robison WG Jr. Retinal Capillary Dilation: Early Diabetic-Like Retinopathy in the Galactose-Fed Rat Model. Journal of Ocular Pharmacology and Therapeutics 16(2):167-172, 2000.
Gutman S and Richter K. New Directions in the FDA Regulation of In Vitro Diagnostic Devices. Laboratory Medicine 30(12):782-785, 1999.
Hackett JL. FDA Takes Over CLIA Complexity Determinations. IVD Technology 6(3):26-28, 2000.
Hellman KJB, Solomon RR, Gaffey C, Durfor CN, and Bishop JG. Regulatory Considerations. In Principles of Tissue Engineering, 2nd edition, edited by R.P. Lanza, R. Langer and J. Vacanti, San Diego, Academic Press, pp 915-927, 2000.
Hirschl R and O’Neill C. Regulatory Issues Related to Extracorporeal Life Support. In ECMO: Extracorporeal Cardiopulmonary Support in Critical Care, 2nd edition, edited by J.B. Zwischenberger, R.H. Steinhorn, and R.H. Bartlett, Ann Arbor, Extracorporeal Life Support Organization, pp 701-706, 2000.
Houn F, Bright RA, Bushar HF, Croft BY, Finder CA, Gohagan JK, Jennings RJ, Keegan P, Kessler LG, Kramer BS, Martynec LO, Robinowitz M, Sacks WM, Schultz, DG, and Wagner RF. Study Design in the Evaluation of Breast Cancer Imaging Technologies. Acad. Radiol. 7:684-92, 2000.
McCullagh L and Baker KH. Endoscope Reprocessing: Taking the Mystery out of HIgh-Level Disinfection. ORL - Head and Neck Nurses 18:1:6-10, Winter 2000.
Moxey-Mims MM, Young G, Silverman A, Selby D, White JG, and Kher KK. End-Stage Renal Disease in Two Pediatric Patients with Fechtner Syndrome. Pediatr. Nephrol. 13(9):782-786, 1999.
Ng CS and Rosenthal AR. Classification & Epidemiology of Uveitis. In Oxford Textbook of Ophthalmology, edited by D.L. Easty and J.M. Sparrow, Oxford University Press, Vol. 1, pp 509-515, 1999.
Ng CS and Rosenthal AR. Principles of Clinical Management of Uveitis. In Oxford Textbook of Ophthalmology, edited by D.L. Easty and J.M. Sparrow, Oxford University Press, Vol. 1, pp 553-559, 1999.
Robison WG Jr., Cook-Ashby JC, Soto I, Kelley MA, Glover JP, and Jacot JL. Identification of Vasculogenic-Like Precursor Cells in the Galactose-Fed Rat Model of Diabetic Retinal Microangiopathies. Investigative Ophthalmology and Visual Science 41(4):S405, 2000.
Robison WG Jr., Jacot JL, Katz ML, and Glover JP. Retinal Vascular Changes Induced by the Oxidative Stress of a -Tocopherol Deficiency Contrasted with Diabetic Microangiopathy. Journal of Ocular Pharmacology and Therapeutics 16(2):109-120, 2000.
Sauberman HR. Food and Drug Administration Approval Process for Cochlear Implants. In Cochlear Implants, Principles and Practices, Appendix 6B; edited by John K. Niparko, M.D., Johns Hopkins University, Lippincott Williams & Wilkins, Philadelphia, pp 122-128, 2000.
Spyker DA, Harvey ED, Harvey BE, Harvey AM, Rumack BH, Peck CC, Atkinson AJ Jr., Woosley RL, Abernethy DR, and Cantilena LR. Assessment and Reporting of Clinical Pharmacology Information in Drug Labeling. Clin. Pharmacol. Ther. 67(3):196-200, 2000.
Abstracts and Presentations
Balow J and Meyers CM. Iatrogenic Nephrotic Syndrome (Graft-vs-Host Disease and Renal Involvement), Federal Medical Monthly Nephrology Seminars, Uniformed Services University of the Health Sciences, Bethesda, MD, March 2000.
Banu N, Mozes MM, Kopp JB, Ziyadeh FN, and Meyers CM. Regulation of Inducible Class II MHC, Costimulatory Molecules, and Cytokine Expression in TGF-1 Knock-Out Renal Epithelial Cells. Effects of exogenous TGF-1. American Society of Nephrology Meeting, Miami, FL, November 1999.
Baker KH and Cygnarowicz T. A Multidisciplinary Approach to Development of a Guidance Document for Implantable Middle Ear Hearing Devices. FDA Science Forum in Washington D.C., February 2000.
Baker KH and McCullagh L. Glove Selection: Choosing the Right Glove for the Job. Society of Otolaryngology/Head and Neck Nurses Annual Congress and Symposium, Washington, D.C., September 2000.
Boulware A, Eydelman MB, Lum F, Silverman P, and Lochner D. Retrospective Evaluation of IOLs in Adults Under 60 Years. Symposium on Cataract, IOL and Refractive Surgery, American Society of Cataract and Refractive Surgery, Boston, MA, May 2000.
Calogero D, Eydelman MB, Arshinoff S, Senft S, Bilotta M, and Hadi H. Endothelial Cell Loss with Viscoelastic Use. Symposium on Cataract, IOL and Refractive Surgery, American Society of Cataract and Refractive Surgery, Boston, MA, May 2000.
Carey CC and Saperstein W. Testing Requirements for Automated External Defibrillators (AEDs). FDA Science Forum, Washington, D.C., February 2000.
Demian, H. A Regulatory Perspective for Orthopedic Bone Cements. 6th World Biomaterials Congress, Kamuela, Hawaii, May 2000.
Eydelman MB, Calogero D, Arsinoff S, Senft S, Bilotta R, and Hadi H. Development of an International Standard for the Clinical Evaluation of New Viscoelastics. American Society of Cataract and Refractive Surgery Annual Meeting, Boston, MA, May 2000.
Forman M, Oberste MS, Ray SC, Pallansch M, and Ticehurst J. Parechovirus Detection by PCR: Interstrain Heterogeneity and Optimization. 16th Annual Clinical Virology Symposium and Annual Meeting, Pan American Society for Clinical Virology, Clearwater Beach, FL, April - May 2000.
Fugate KJ, Vadlamudi S, Turkeltaub P, and Noah C. Development of an In-Vitro IgE Test for Ethylene Oxide Hypersensitivity: A CRADA Study and Technology Transfer Agreement with Diagnostic Product Corporation, Inc., National Institutes of Health and Centers for Disease Control and Prevention. FDA Science Forum, Washington, D.C., February 2000.
Gatling, RR. Review of Various PMA Approaches. AdvaMed's Tenth Annual Device Submissions Workshop, Washington, D.C., July 2000.
Gatling, RR. Modifications to Devices Subject to Premarket Approval - The PMA Supplement Decision Making Process. AdvaMed's Tenth Annual Device Submissions Workshop, Washington, D.C., July 2000.
Gatling, RR. 30-Day Notices and 135-Day PMA Supplements for Manufacturing Changes. AdvaMed's Tenth Annual Device Submissions Workshop, Washington, D.C., July 2000.
Gatling, RR. Least Burdensome Provisions of FDAMA. 11th Annual Medical Device Technology European Conference, Paris, France, September 2000.
Harvey B. The Place of Virtual Bronchoscopy in Clinical Practice: Barriers and Solutions. International Society for Optical Engineering (SPIE), Medical Imaging 2000, San Diego, CA, February 2000.
Harvey B. FDA Premarket Regulatory Requirements for In Vitro Diagnostic Devices. Health Care Financing Administration (HCFA) Laboratory & Diagnostic Services Panel, Public Advisory Panel Meeting, Baltimore, MD, November 1999.
Harvey B. How the FDA, Industry and Clinicians Deal with New Medical Information. American College of Gastroenterology Ad Hoc Committee on FDA Related Matters, 64th Annual Scientific Meeting, American College of Gastroenterology, Phoenix, AZ, October 1999.
Harvey B. The Regulation of Medical Devices by the U.S. Food and Drug Administration: the Rest of the Story. Gastroenterology Grand Rounds, University of Virginia School of Medicine, Charlottesville, VA, October 1999.
Harvey E, Mitchell D, and Schultz D. Preclinical Animal and Clinical Testing Guidelines for New Adhesion Barriers, 4th International Conference on Postoperative Healing, Ft. Lauderdale, FL, October 1999.
Ho C. Assessment of the Shelf Lives of Cardiac Devices. FDA Science Forum, Washington, D.C., February 2000.
Horbowyj R. Publishing in International Medical Literature. World Federation of Ukranian Medical Associations, VIII Congress, Lviv, Ukraine, August 2000.
Jevtich MJ. FDA Experience with Modern BPH Devices and Regulatory Process. 5th International Consultatio on BPH (WHO), Paris, France, June 2000.
Kammula R. Use of FDA Recognized Standards and Master Files to Address Biocompatibility. Medical Design and Manufacturing (MD&M) East Conference, New York City, NY, June 2000.
Maxim PE. Pharmacogenomics: A Regulatory Perspective. The Second Annual Pharmacogenomics Event, London, England, January 2000.
Maxim PE. FDA Review of In Vitro Medical Devices (informal presentation to staff). Medical Devices Agency, London, England, January 2000.
Maxim PE. Performance Studies for Allergen Reagents. Technical Consultant Meeting on IgE Allergy Testing, CDC, Atlanta, GA, April 2000.
Maxim PE. FDA and Genetic Testing. HCFA-RO Laboratory Conference, Baltimore, MD, May 2000.
Maxim PE. FDA Regulation of In Vitro Medical Devices. Tri-Service Clinical Investigation Postgraduate Short Course, San Antonio, TX, May 2000.
Maxim PE. Clinical Trials: What the FDA’s New IVD Policy Means to You, AACC Teleconference, Rockville, MD, June 2000.
Maxim PE. FDA and Genetic Testing: An Update on SACGT Proceedings. Professional Roundtable, Rockville, MD, June 2000.
Maxim PE. Role of International Standards and Reference Materials in FDA Regulation of IVDs. WHO Consultation on International Biological Standards, Geneva, Switzerland, September 2000.
Maxim PE. Data Requirements for 510(k) Submissions to DCLD. AMDM In Vitro Diagnostics 510(k) Workshop, Rockville, MD, September 2000.
Melkerson M. To Evaluate Why, What and Wherein Orthopedic Device Standards: Planning for 2000 and Beyond. American Society for Testing and Materials, Toronto, Canada, May 2000.
Meyers CM and Jevnikar A. Breakthroughs and Hot Topics in Cellular Immunity. Scientific Session Moderators. American Society of Nephrology Meeting, Miami, FL, November 1999.
Michaud G. Quality Control of Point of Care Coagulation Devices. The 46th SSC Meeting of the ISTH, Maastricht, The Netherlands, June 2000.
Michaud G. Novel Designs with Traditional Names. When Should an Assay be Given a New Name? The 46th SSC Meeting of the ISTH, Maastricht, The Netherlands, June 2000.
Morris JM. Regulatory Considerations for Emerging Surface Technology, Surfaces in Biomaterials 2000, Scottsdale, AZ, September 2000.
Neuland CY. Requesting Evaluation of an Automatic Class III Designation. HIMA Workshop: Getting to Market Sooner, Washington, D.C., December 1999.
Pollard CM. In Vivo Diagnostic Spectroscopy: Regulatory Considerations for Clinical Trials and Premarket Clearance, Optical Society of America, Miami Beach, FL, April 2000.
Poole FM. FDA Requirements for Microbiological Specimen Transport System. NCCLS Subcommittee for Quality Control of Microbiological Transport Systems, February 2000.
Rechen, EJ. Third-Party Review of 510(k)s. HIMA Workshop: Getting to Market Sooner, Washington, D.C., December 1999.
Rechen, EJ. Third Party Review. AdvaMed's Tenth Annual Device Submissions Workshop, Washington, D.C., July 2000.
Rechen, EJ. FDA's 510(k) Third-Party Review Program, CBER Blood Products Advisory Committee Meeting, Gaithersburg, MD, September 2000.
Rechen, EJ. FDA's 510(k) Third-Party Review Program, FDA Medical Device Workshop, Depew, NY, September 2000.
Robison WG Jr., Glover JP, Jacot JL, Basso MD, Hohman TC. ARI Prevention of Retinal Capillary Dilation, an Early Diabetic-Like Microangiopathy in the Galactose-Fed Rat Model. US-Japan Aldose Reductase Workshop, Kona, Hawaii, January 2000.
Robison WG Jr., Jacot JL, Katz ML, Glover JP. Relative Roles of Oxidative Stress and Elevated Aldose Reductase Activity in the Microangiopathies of Diabetic Retinopathy. US-Japan Aldose Reductase Workshop, Kona, Hawaii, January 2000.
Rosenthal AR and Eydelman MB. A Guide to Ophthalmic Device Evaluation. American Academy of Ophthalmology, Orlando, FL, October 1999.
Schultz D. Technology Assessment, An FDA Perspective. American College of Surgeons Annual Clinical Conference, San Francisco, CA, October 1999.
Shively RG. Design Issues for Nucleic Acid Amplification Testing. TB Task Force Meeting, NIH, Bethesda, MD, December 2000.
Shulman, M. Premarket Notification (510(k)s). Dallas District FDA/Industry Medical Device Coalition, Dallas, TX, October 1999.
Shulman, M. Implementation of the 510(k) Paradigm and Premarket Notification. Medical Design and Manufacturing (MD&M) Minneapolis, MN, October 1999.
Shulman, M. Premarket Notification and FDA CDRH Hot Topics for 2000. Medical Design and Manufacturing (MD&M) East Conference, New York City, NY, June 2000.
Shulman, M. Premarket Notification Regulatory Review. AMDM In Vitro Diagnostics 510(k) Workshop, Rockville, MD, September 2000.
Ticehurst J. Evidence Based Diagnostic Virology. 16th Annual Clinical Virology Symposium and Annual Meeting, Pan American Society for Clinical Virology, Clearwater Beach, FL, April - May 2000.
Ticehurst J. FDA Approaches to Assays for Diagnosis or Monitoring of HCV Infections. Association of Public Health Laboratories Conference on Laboratory Aspects of Human Retrovirus & Hepatitis C Testing, Charlotte, NC, March 2000.
Whitaker KB, Shively RG, and Dubois W. CDRH Perspective on Nucleic Acid Amplification Testing. FDA/Industry Training Co-sponsored by FDA and Gen-Probe, Inc., Roche Molecular Systems, Chiron/Bayer Diagnostics, and Organon Teknika, May 2000.
Zhou S and Hoang Q. Test for Comparability of Excimer Lasers. FDA Science Forum, Washington, D.C., February 2000.
Staff College Presenters and Faculty
|Aziz, Kaiser||Less, Joanne||Rechen, Eric|
|Beers, Everette||Melvin, Marsha||Romanell, Lawrence|
|Brown, Daniel W.C.||Mishra, Nirmal||Rosecrans, Heather|
|Durfor, Charles||Morris, Janine||Shulman, Marjorie|
|Gantt, A. Doyle||Neuland, Carolyn||Sliva, Clara|
|Goode, Jennifer||Nutter, Cathy||Tillman, Donna-Bea|
|Gutman, Steve||Nguyen, Trinh||Turtil, Steven|
|Horbowyj, Roxolana||Phillips, Robert||Ulatowski, Tim|
|Kammula, Raja||Phillips, Philip||Weitershausen, Joanna|
|Kennell, Lisa||Poneleit, Kathy||Witten, Celia|
|Lacy, Frank||Portnoy, Stuart||Zuckerman, Bra|