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Publications

Publications

1.         Pietzsch JB. Richter A-K, Randerath W, Steffen A, Liu S, Geisler BP, Wasem J, Biermann-Stallwitz J. “Clinical and Economic Benefits of Upper Airway Stimulation for Obstructive Sleep Apnea in a European Setting,” Respiration.

2.         Geisler BP, Jilg N, Patton RG, Pietzsch JB. "A Model to Evaluate the Impact of Hospital-Based Interventions Targeting False-positive Blood Cultures on Economic and Clinical Outcomes." J Hosp Infect. 2019 Mar 27. pii: S0195-6701(19)30145-8. doi: 10.1016/j.jhin.2019.03.012. 

3.         Peiffer V, Yock CA, Yock PG, Pietzsch JB. “Value-Based Care: A Review of Key Challenges and Opportunities Relevant to Medical Technology Innovators,” Journal of Medical Devices.

4.        Schaefer A, Lubos E, Pietzsch JB, Pietzsch M, Weber S, Blankenberg S, Reichenspurner H, Schäfer U, Conradi L. “Insights from eight years of adoption experience of transcatheter mitral valve repair in Germany: observed utilisation patterns and impact on overall mitral valve procedure volumes,” EuroIntervention. 2018;14(9):e981–e987; doi: 10.4244/EIJ-D-18-00403.

5.         Pietzsch JB, Busca R, Rott C, Geisler BP, Weber SA, Slebos DJ, Deslee G, Herth FJF. “Adoption Patterns of Bronchoscopic Lung Volume Reduction Procedures in Germany and Predicted Procedure Volumes for Other European Countries,” Respiration. 2018; Epub ahead of print, 17 August 2018; doi: 10.1159/000491677.

6.         Perl L, Peiffer V, Fuhrer A, D’Ascenzo F, Pietzsch JB. “Sex differences in discharge destination following acute myocardial infarction,” Coronary Artery Disease: September 2018 – Volume 29 – Issue 6 – p 502–510.doi: 10.1097/MCA.0000000000000643

7.         Pietzsch JB, Weber SA, Lund N, Gaul C.  “Changes in Medication Cost Observed in Chronic Cluster Headache Patients Treated with Sphenopalatine Ganglion (SPG) Stimulation: Analysis Based on 1-Year Data from the Pathway R-1 Registry,” Cephalalgia. 2018;38(8)1455–1462; doi: 10.1177/0333102418784689.

8.         Faucett SC, Geisler BP, Chahla J, Krych AJ, Kurzweil PR, Garner AM, Liu S, LaPrade RF, Pietzsch JB. “Meniscus Root Repair vs Meniscectomy or Nonoperative Management to Prevent Knee Osteoarthritis after Medial Meniscus Root Tears: Clinical and Economic Effectiveness,” Am J Sports Med. 2018; Epub ahead of print, 1 March 2018; doi: 10.1177/0363546518755754.

9.         Geisler BP, Huygens SA, Reardon MJ, Van Mieghem N, Kappetein AP, Osnabrugge RLJ, Pietzsch JB. Cost-effectiveness and projected survival of self-expanding transcatheter versus surgical aortic valve replacement for high-risk patients in a European setting: a Dutch analysis based on the CoreValve high-risk trial. Structural Heart. Online ahead of print Sept. 9, 2017; doi: 10.1080/24748706.2017.1381357.

10.        Pietzsch JB, Geisler BP, Ikeno F. Cost-effectiveness of orbital atherectomy compared to rotational atherectomy in treating patients with severely calcified coronary artery lesions in Japan. Cardiovasc Interv Ther. 2017;Epub ahead of print, 5 September 2017; doi: 10.1007/s12928-017-0488-3.

11.        Feller-Kopman D, Liu S, Geisler BP, DeCamp M, Pietzsch JB. Cost-Effectiveness of a Bronchial Genomic Classifier for the Diagnostic Evaluation of Lung Cancer. J Thorac Oncol. 2017 May 11. pii: S1556-0864(17)30364-7. doi: 10.1016/j.jtho.2017.04.030.

12.         Pietzsch JB, Garner AM, Marks WJ. Cost-Effectiveness of Deep Brain Stimulation for Advanced Parkinson's Disease in the United States. Neuromodulation: Technology at the Neural Interface. doi:10.1111/ner.12474, August 2016.

13.         Katsanos K, Geisler BP, Garner AM, Zayed H, Cleveland T, Pietzsch JB. Economic Analysis of Endovascular Drug-eluting Treatments for Femoropopliteal Artery Disease in the United Kingdom. Accepted for publication, British Medical Journal (BMJ) Open, April 2016.

14.         Feeley BT, Liu S, Garner AM, Zhang AL, Pietzsch JB. The Cost-Effectiveness of Meniscal Repair versus Partial Meniscectomy: A Model-Based Projection of Clinical Outcomes and Costs in the United States Healthcare System. The Knee; 23: 674-680, April 2016.

15.         Noblett KL, Dmochowski RR, Vasavada SP, Garner AM, Liu S, Pietzsch JB. Cost profiles and budget impact of rechargeable versus non-rechargeable sacral neuromodulation devices in the treatment of overactive bladder syndrome. Neurourol Urodyn. 2016 Apr 6. doi: 10.1002/nau.23008. [Epub ahead of print]

16.         Pietzsch JB, Liu S, Garner AM, Kezirian EJ, Strollo PJ. Long-Term Cost-Effectiveness of Upper Airway Stimulation for the Treatment of Obstructive Sleep Apnea: A Model-Based Projection Based on the STAR Trial. Sleep 2015;38:735-44.

17.         Pietzsch JB, Garner A, Gaul C, May A. Cost-effectiveness of stimulation of the sphenopalatine ganglion (SPG) for the treatment of chronic cluster headache: a model-based analysis based on the Pathway CH-1 study. The Journal of Headache and Pain 2015;16:530.

18.         Pietzsch JB, Garner A, McQueen M. Economic Impact Of Changes In NICU Ventilation Strategies With The Advent Of New Noninvasive Ventilation Techniques: A Review And Proposed Assessment Framework For High Flow Therapy (HFT) as a Routine Respiratory Support Paradigm. The Journal of Health Economics and Outcomes Research (JHEOR) 2015;3(1):34-42.

19.         Conradi L, Lubos E, Treede H, Pietzsch JB, Weber S, Pietzsch M, Overlack K, Diemert P, Blankenberg S, Reichenspurner H. Evolution of mitral valve procedural volumes in the advent of endovascular treatment options: Experience at an early-adopting center in Germany. Catheter Cardiovasc Interv. 2015 Nov 15;86(6):1114-9.

20.         Pietzsch JB, Geisler BP, Garner AM, Zeller T, Jaff MR. Economic analysis of endovascular interventions for femoropopliteal arterial disease: a systematic review and budget impact model for the United States and Germany. Catheterization and Cardiovascular Interventions 2014;84:546-54.

21.       Pietzsch JB, Garner A, Herth FJ. Cost-effectiveness of endobronchial valve therapy for severe emphysema: a model-based projection based on the VENT study. Respiration 2014;88:389-98.

22.       Pietzsch JB, Zanchi MG, Linehan JH. Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience—Part 2: Medical Device Ecosystem and Policy. Journal of Medical Devices 2013;7:021003-.

23.       Brinton TJ, Kurihara CQ, Camarillo DB, Pietzsch JB, Gorodsky J, Zenios SA, Doshi R, Shen C, Kumar UN, Mairal A, Watkins J, Popp RL, Wang PJ, Makower J, Krummel TM, Yock PG. Outcomes from a postgraduate biomedical technology innovation training program: the first 12 years of Stanford Biodesign. Annals of Biomedical Engineering 2013;41:1803-10.

24.       Geisler BP, Egan BM, Cohen JT, Garner AM, Akehurst RL, Esler MD, Pietzsch JB. Cost-effectiveness and clinical effectiveness of catheter-based renal denervation for resistant hypertension. Journal of the American College of Cardiology 2012;60:1271-7.

25.       Pietzsch JB, Zanchi MG, Linehan JH. Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience. Journal of Medical Devices 2012;6:021015-.

26.       Pietzsch JB, Garner A, Cipriano LE, Linehan JH. An integrated Health-economic Analysis of Diagnostic and Therapeutic Strategies in the Treatment of Moderate-to-Severe Obstructive Sleep Apnea. Sleep 2011;34:695-709.

27.       Rao SK, Pietzsch JB. Policy-Induced Constraints in the Design and Commercialization of Monitoring Devices: An Assessment of Three Technologies’ Reimbursement Models. Journal of Medical Devices 2009;3:024502-.

28.       Pietzsch JB, Shluzas LA, Paté-Cornell ME, Yock PG, Linehan JH. Stage-Gate Process for the Development of Medical Devices. Journal of Medical Devices 2009;3:021004-.

29.       Arrow K, Auerbach A, Bertko J, Brownlee S, Casalino LP, Cooper J, Crosson FJ, Enthoven A, Falcone E, Feldman RC, Fuchs VR, Garber AM, Gold MR, Goldman D, Hadfield GK, Hall MA, Horwitz RI, Hooven M, Jacobson PD, Jost TS, Kotlikoff LJ, Levin J, Levine S, Levy R, Linscott K, Luft HS, Mashal R, McFadden D, Mechanic D, Meltzer D, Newhouse JP, Noll RG, Pietzsch JB, Pizzo P, Reischauer RD, Rosenbaum S, Sage W, Schaeffer LD, Sheen E, Silber BM, Skinner J, Shortell SM, Thier SO, Tunis S, Wulsin L, Jr., Yock P, Nun GB, Bryan S, Luxenburg O, van de Ven WP. Toward a 21st-century health care system: recommendations for health care reform. Annals of Internal Medicine 2009;150:493-5.

30.       DiDomenico PB, Pietzsch JB, Pate-Cornell ME. Bayesian assessment of overtriage and undertriage at a level I trauma centre. Philosophical Transactions of the Royal Society, Series A, Mathematical, physical, and engineering sciences 2008;366:2265-77.

31.       Pietzsch JB, Pate-Cornell ME. Early technology assessment of new medical devices. International Journal of Technology Assessment in Health Care 2008;24:36-44.

32.       Pietzsch JB, Aquino LM, Yock PG, Paté-Cornell ME, Linehan JH. Review of U.S. Medical Device Regulation. Journal of Medical Devices 2007;1:283-92.

33.       Haberland CA, Benitz WE, Sanders GD, Pietzsch JB, Yamada S, Nguyen L, Garber AM. Perinatal screening for group B streptococci: cost-benefit analysis of rapid polymerase chain reaction. Pediatrics 2002;110:471-80.

34.       Pietzsch JB, Gemuenden HG, Bolz A. [Conditions and success factors of telemedicine innovation]. Biomedizinische Technik Biomedical Engineering 2001;46:96-100.

 

Conference Proceedings (selected)

1.         Feller-Kopman D, Liu S, Garner AM, Decamp M, Pietzsch JB. Cost-Effectiveness of the Percepta Bronchial Genomic Classifier for the Diagnostic Evaluation of Lung Cancer: An Analytical Framework based on the AEGIS Studies. Presentation at American Thoracic Society (ATS) Annual Meeting 2016. Respir Crit Care Med 2016.

2.         Geisler BP, Osnabrugge RL, Huygens SA, Reardon MJ; Kappetein AP, Pietzsch JB. Cost-effectiveness of TAVI vs. surgical aortic valve replacement: the CoreValve High Risk trial from a European perspective. Presentation at EuroPCR 2016, EuroIntervention May 2016.

3.         Pietzsch JB, Geisler BP, Schmieder R., Egan BM. Cost-effectiveness threshold analysis of various age and systolic blood pressure reduction scenarios for renal denervation therapy. Presentation at EuroPCR 2016, EuroIntervention May 2016.

4.         Pietzsch JB, Weber SA, Pietzsch ML, Zeller T. The Impact Of New Endovascular Therapies For Femoropopliteal Arterial Disease On Therapy Utilization And Case Volumes In Germany, 2009-2013. Value Health. 2015 Nov;18(7):A366.

5.         Pietzsch JB, Busca R, Geisler BP. Adoption Of Transcatheter Aortic Valve Replacement In Germany: Utilization Patterns And Case Volumes Compared To Surgical Aortic Valve Replacement In The Period 2009-2013. Value Health. 2015 Nov;18(7):A370.

6.         Busca R, Geisler BP, Pietzsch JB. Cost-Effectiveness of Transcatheter Aortic Valve Replacement: Current Decision-Analytic Models and Future Opportunities. Value Health. 2015 Nov;18(7):A359.

7.         Pietzsch JB, Geisler BP, Zeller T. Endovascular Interventions For Treatment Of Femoropopliteal Peripheral Artery Disease: Updated Budget Impact Analysis For Germany Based On Latest Clincal Evidence. Value Health. 2015 Nov;18(7):A349.

8.         Pietzsch JB, Geisler B, Esler M. Estimated Added Benefit Of Catheter-Based Renal Denervation For Moderate Treatment-Resistant Hypertension: Impact Of Age And Cardiovascular Risk Factors. Value in Health 2014;7:A474.

9.         Valencia J, Diaz-Sotelo O, Alfonso-Cristancho R, Castro TB, Pietzsch JB. Cost-effectiveness analysis of catheter based renal denervation (RDN) for resistant arterial hypertension in Colombia. Value in Health 2013;3:A286.

10.       Sadri H, Pietzsch JB, Geisler B, Padwal R, Vallée M, Feldman R. Cost-effectiveness of catheter-based renal denervation for resistant hypertension–a Canadian perspective. Value in Health 2013;16:A284-A5.

11.       Pietzsch JB, Geisler B, Esler M. Gender differences in added benefit of catheter-based renal denervation for resistant hypertension: model-based estimation of unadjusted and quality-adjusted life year gains in males and females. European Heart Journal 2013;34:P4491.

12.       Pietzsch JB, Geisler B, Esler M. Efficacy and clinical and economic effectiveness in resistant hypertensive subgroups. Journal of the American College of Cardiology 2012;59:E1716-E.

13.       Pietzsch JB, Geisler B, Jaff M. Budget Impact of Drug Eluting Balloons for Intermittent Claudication From Superficial Femoral Artery Disease in the United States Health Care System. Value in Health 2012;15:A348.

14.       Pietzsch JB, Geisler B, Akehurst R. Long-Term Clinical Effectiveness and Cost-Effectiveness of Catheter-Based Renal Denervation in the UK. A Model-Based Projection Based on the Symplicity HTN-2 Trial. Value in Health 2012;15:A349.

15.       Geisler B, Cohen J, Neumann P, Pietzsch JB. New Approaches for Graphing Probabilistic Patient-Relevant Health Outcomes: The Case of Renal Denervation for Resistant Hypertension. Value in Health 2012;15:A72.

16.       Linehan J, Pietzsch JB. A Comprehensive Analysis of the FDA 510 (k) Process. National Press Club briefing, May; 2011.

17.       Shluzas LA, Pietzsch JB, Paté-Cornell ME, Yock PG, Linehan JH. The Iterative Nature of Medical Device Design.  DS 58-1: Proceedings of ICED 09, the 17th International Conference on Engineering Design, Vol 1, Design Processes, Palo Alto, CA, USA, 24-2708 2009; 2009.

18.       Pietzsch J, Garner A, Linehan J. An End-to-End Analytical Model of OSA Diagnosis and Therapy Assessing the Impact of Technology and Policy Choices on Patient Outcomes. Am J Respir Crit Care Med 2009;179:A3583.

19.       Pietzsch J, Paté-Cornell ME, Krummel T. A Framework for Probabilistic Assessment of New Medical Technologies. In: Spitzer C, Schmocker U, Dang V, eds. Probabilistic Safety Assessment and Management: Springer London; 2004:2224-9.
 

Patent Applications

Kanthi Kiran, James M. Lovette, Nicholas Mourlas, Jan B. Pietzsch, “Methods and Devices for Modulating Atrial Configuration," patent application filed with the U.S. Patent and Trademark Office (PTO Reg. No. 10/388,606) through Stanford Office of Technology Licensing, March 2003.

Kanthi Kiran, James M. Lovette, Jan B. Pietzsch, “Catheter-Based Delivery of RF-Energy to Modify the Left Atrium to Prevent Clot Formation in Chronic Atrial Fibrillation Patients,” provisional patent application filed with the U.S. Patent and Trademark Office (PTO Reg. No. 60/364,165) through Stanford Office of Technology Licensing, March 2002.

 

Invited Lectures and other Presentations (selection)

Wilson Sonsini Goodrich & Rosati Medical Devices Conference. Presentation and panel judge, “Medtech Innovator 2016” session. San Francisco, CA, June 24, 2016.

Japan Endovascular Therapies (JET) 2016. Presentations in sessions “Medical Economics – Town Hall discussion” and “Prediction of the latest outcomes of SFA interventions.” Fukuoka, Japan, Feb. 20, 2016.

The Heart.org/Medscape Education Cardiology. “Economic Implications of Uncontrolled Hypertension” Interview/Webinar. Course Faculty: Michael A. Weber, MD; David J. Cohen, MD; Jan B. Pietzsch, PhD. Dallas, TX, Nov. 2013 (available online, CME education).

EFPL École polytechnique fédérale de Lausanne (Swiss Federal Institute of Technology), Lausanne, Switzerland, April 18, 2012. Two guest lectures in Executive MBA Program in Management of Technology “Assessing the Value of New Ventures”. Lecture titles: “The medtech development process and value creation” and “Early-stage opportunity assessment and investor considerations.”

TREND 2012 Workshop - Catheter and Device Based Treatment of Hypertension and Heart Failure, Frankfurt, Germany, Feb. 18, 2012. Presentation Title: “Model-based Projection of the long-term clinical and economic benefit of Renal Denervation.”

1st UK Symposium on Renal Denervation, Royal College of Physicians, London UK, Oct. 5, 2011. Participation in Session: “Renal Denervation in Clinical Practice and Special Situations.” Presentation Title: “Health Economics of Renal Denervation.”

NAMT 2011 DFG Nachwuchsakademie Medizintechnik, Berlin, Germany, August 25, 2011. Presentation and podium discussion: “Biopharmaceutical development and health economics” (with Dr. Barbara Pfüller).

Alliance of Specialty Medicine – Capitol Hill Advocacy Conference, Washington DC, July 12, 2011. Issues Panel. Presentation title: “The 510(k) Survey: Results and Lessons”.

National Press Club, Washington DC, May 24, 2011. News Conference “A Comprehensive Analysis of the FDA 510(k) Process – Industry Practice and Implications for Reform”. Presentation Title: “The 510(k) Survey – Results and Lessons”. (with John Linehan, Ph.D.).

RAPS Horizons Conference 2011, Vancouver, Canada, April 7, 2011. Presentation and Panel Participation in Session “The Tipping Point: Sector-specific Considerations - Medical Devices”. Presentation Title: “Medtech Innovation and Regulation – Trends, Challenges, and Opportunities”.

CC-ATMP Competence Center for ATMP Development, Berlin, Germany, January 27, 2011. Symposium “Vom präklinischen Proof of Concept zur Erstattung – effiziente Prozessgestaltung in der Regenerativen Medizin“, Berlin, Germany, January 27, 2011. Presentation Title: “Einführung Gesundheitsökonomie” (Introduction to Health Economics) [in German].

National University of Ireland/BioInnovate Ireland, Galway, Ireland, January 21, 2011. Briefing and presentation “Accelerating Medical Device Innovation: The Role of Training”. (with John Linehan, Ph.D.).

Irish Medical Devices Association (IMDA), Galway, Ireland, January 20, 2011. Half-day executive training session as part of day-long program “Health Technology Assessment (HTA) Workshop”.

Irish Medical Devices Association – Medical Devices & Diagnostics Leadership Programme, Galway, Ireland, January 19, 2011. Day-long executive workshop/training program “Marketing of Medical Devices”.

OneMedForum SF 2011 Investor Conference, San Francisco, CA, January 11, 2011. Presentation and Participation in Session “Improving the FDA 510(k) Process - Lessons Learned from Recent Benchmarking Studies”. Presentation Title: “A Comprehensive Analysis of the FDA 510(k) Process”.

Institute for Health Technologies (InHealth) Research webcast, December 22, 2010. Presentation and participation webcast, Title: “Industry, Agency, and the 510(k) Process – An Industrywide Survey”.

2010 RAPS Regulatory Affairs Professional Society Annual Conference, San Jose, CA, October 26, 2010. Presentation and Participation in Session “510(k) Program Update".

IMD International Medical Devices Expo and Conference, San Jose, CA, Sept. 29, 2010. Presentation and Participation in Session "Global Opportunities & Challenges in Medical Device Development". Presentation Title: "Europe: The New Proving Ground for Innovation in Medical Devices."

Health Technology Assessment International (HTAi) Annual Meeting, Dublin/Ireland, June 7, 2010. Panel Participation – Panel Title: “Demand forecasting and early modeling in medical technology development - from theory to maximized value of HTA in practice." Presentation Title: "Early modeling to support investment and design decisions in medical device development."

Stanford Medical Innovation Conference 2010, Stanford University, Stanford, CA, April 10, 2010. Panel Participation, Panel Title: "The Future of Medical Robotics."

Northwestern University, Chicago, Jan. 29, 2010. BME Department Seminar. Lecture Title: "Thinking ahead - Value-based assessment of medical technology innovations in an era of health care reform."

World Health Summit 2009, Berlin/Germany, Oct. 15, 2009. Presentation and participation in Panel "How to Reimburse Innovations in Regenerative Medicine?" Presentation Title: "Health Technology Assessment and Reimbursement of Innovative Technologies in the International Context - Overview and Implications."

BSRT International Summer School on Regenerative Therapies, Berlin, Germany, July 29, 2009, Keynote Lecture, Title: "Health-economic concepts for tissue regeneration."

BSRT International Summer School on Regenerative Therapies, Berlin/Germany, July 29, 2009. Keynote Lecture. Title: “Health-Economic Concepts for Tissue Regeneration” (forthcoming)

Advamed 2009 Emerging Growth Company Conference, Newport Beach, CA, May 5. 2009. Invited talk. Title: “What is the best model for device development?”

Stanford Center for Professional Development (SCPD) Online Webinar, March 10, 2009. Title: “Focus on Innovation: New Trends in Technology Assessment and Regulation of Medical Devices”

Medical Design & Manufacturing (MD&M) and MEDTEC meetings, June 2008 – April 2009: Chair and co-Chair of day-long conference sessions "Effective Medical Device and Diagnostics Development." New York (6/2008), Minneapolis (10/2008), Anaheim (2/2009), Stuttgart/Germany (2/2009), Birmingham/UK (3/2009), Yokohma/Japan (4/2009).

Symposium "Principles and Applications of Adoptive T-Cell Therapy", Berlin, Germany, May 28, 2008, Title: “Challenges of Translating T cell Therapy from Bench to Bedside – Health-economic Considerations and Reimbursement”

InHealth Conference 'A Road Map for Device and Diagnostic Innovation: Opportunities for Industry and Regulators', Washington DC, April 30, 2008, Title: "The Medical Dervice Innovation Process" (together with John Linehan, Ph.D.).

NHS "World Leaders in Medical Innovations" Conference, London (UK), April 23, 2008, Global Trends & Innovations in Medical Devices, Title: "The evidence does not lie: What's happening to the medical device industry"

BIOMEDevice Forum, San Jose, CA, October 3, 2007, IP and Technology Development Session, Title: “Defining the Product Development Process” (together with John Linehan, Ph.D.).

AdvaMed 2007 Medical Technology Conference, Washington, D.C. October 2, 2007, Title: “Device and Diagnostic Development: The Bridge Bench to Bedside” (together with John Linehan, Ph.D., and M. Elisabeth Paté-Cornell, Ph.D.).

AdvaMed 2007 Medical Technology Conference, Washington D.C. October 1, 2007, Title: “The Challenges for Innovation Facing Emerging Growth Companies”

InHealth Annual Symposium 2007 – Accelerating Technological Change – Value and Health Care Reform, Washington DC, July 16, 2007, Title “The Course of Device Development Never Did Run Smooth” (together with John Linehan, Ph.D.)

Workshop 'Unternehmerische Charité', Berlin, Germany, July 7, 2007, Title: "Abschätzung von Marktpotentialen" [in German]

INFORMS Annual Meeting, Applied Decision-Making in Health Care session, Pittsburgh, P.A. November 6, 2006, Title: "Strategic Decision-Support for Medical Technology Commercialization - Methods and Case Application"

FDA Staff College 'Meet the Experts' Seminar Series, Title:  “Early Technology Assessment of New Medical Devices", Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Rockville MD, November 1, 2004.