The Pathway to Market for Your Medical Device:
A Primer on Obtaining Information from FDA
by Jeffrey K. Shapiro, a Director at the law firm of Hyman, Phelps & McNamara PC in Washington, DC

Medical Devices and Preemption: Riegel, Kent… and Beyond

by Ralph F. Hall, a Distinguished Visiting Practitioner and Professor of Law at the University of Minnesota Law School, Counsel to Baker & Daniels in Indianapolis, IN and Washington, DC and CEO of MR3 Medical LLC

Claims and 510(k) Requirements: An Area of Uncertainty for Medical Devices

by Philip J. Phillips, Director, Medical Device Practice at Becker & Associates Consulting, Inc. in Washington, DC

and

Kristin M. Zielinski, Vice President, Strategic Consulting Group at Becker & Associates Consulting, Inc. in Washington, DC

Computer and Software Devices: FDA Seeks Framework for Regulation
by M. Elizabeth Bierman, a Partner with the law firm of Morgan, Lewis & Bockius, LLP in Washington, DC

and

Michele L. Buenafe, an Associate with the law firm of Morgan, Lewis & Bockius, LLP in Washington, DC

Supplier Quality Management:
Avoiding Common Pitfalls when Outsourcing Medical Devices
by Steven Niedleman, Executive Vice President with the Regulatory and Quality practice at Quintiles Consulting in Rockville, MD

and

Kristen Grumet, Director of Medical Device Quality Systems and Validation Services at Quintiles Consulting in Rockville, MD

Institutional Conflicts of Interest: Identifying and Managing Them in Life Sciences
by Eric Hargan, Partner in the law firm of McDermott Will & Emery LLP in Chicago, IL

Personalized Medicine: Patient Implications for Its Commercialization
by Carol Isaacson Barash, Principal at Genetics, Ethics & Policy Consulting in Boston, MA

Drug Safety and Risk Management Practice: What Drug Companies Can Do

by Mei Sheng Duh, Vice President at Analysis Group in Boston, MA

and

Paul E. Greenberg, Managing Principal and Co-Director of the Health Care practice at Analysis Group in Boston, MA

and

Lucia Antràs, Manager at Analysis Group in Boston, MA

USP’s Food Chemicals Codex: A Way to Enhance Food Safety Standards?
by Ben A. Firschein, Director of Government Affairs at United States Pharmacopeia

and

James C. Griffiths, Vice President, Food and Dietary Supplement Standards at United States Pharmacopeia

Follow-On Biologics in Canada: A Look at the New Draft Guidelines
by Eileen McMahon, Co-Chair of Intellectual Property Practice at the law firm of Torys LLP in Toronto, Ontario, Canada

and

Teresa Reguly, Intellectual Property law practice at the law firm of Torys LLP in Toronto, Ontario, Canada