Regulatory Affairs Publications & Presentations

• CIMIT Innovation Congress 2007: Regulatory Impact On Commercialization Strategy - Premarket Considerations

• Perception and Process at the Food and Drug Administration: Obligations and Trade-Offs in Rules and Guidances (Volume 60, Issue 1, Food and Drug Law Journal; reprinted with permission from FDLI.)

• Medical Device Development: From Prototype to Regulatory Approval (Circulation. 2004; 109:3068-3072)

• Post-Market Approval Surveillance: A Call for a More Integrated and Comprehensive Approach (Circulation. 2004; 109:3073-3077)

• Potential Legal Barriers to Increasing CMS/FDA Collaboration: The Law of Trade Secrets and Related Considerations (Volume 58, Food and Drug Law Journal; reprinted with permission from FDLI.)

• Financial Conflict of Interest in Medical Research: Overview & Analysis of Institutional Controls (Volume 58, Issue 2, Food and Drug Law Journal; reprinted with permission from FDLI.)

• Bringing New Medical Technology to Market: Understanding CMS Coverage and Payment Determinations*

• Financial Conflict of Interest in Medical Research: Overview & Analysis of Federal and State Controls (Volume 57, Issue 3, Food and Drug Law Journal; reprinted with permission from FDLI.)

*Copyright by the Regulatory Affairs Professionals Society (RAPS). Posted with permission on www.cimit.org. This article may not be published, reposted or redistributed without express permission from RAPS and payment of appropriate fees when applicable. To obtain such permission, send a message to reprints@raps.org