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Issue 4 : July/August 2008


When it comes to reimbursement,
it's a jungle out there
July/August 2008

Subscription Information

FDLI members receive Update as part of membership.
Additional copies or back issues are available at $15 each.
*Please contact FDLI at (800) 956-6293 or
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.


Featured Articles


Reimbursement for Drugs and Devices: At a Tipping Point?
by Ted R. Mannen, a Member of the law firm of Epstein Becker & Green, PC, Washington, DC

and

Paul Campbell, Senior Advisor to the law firm of Epstein Becker & Green, PC, Washington, DC

Succeeding In the Market Place: The Importance of Pricing, Reimbursement
and Patient Access Strategies

by Charles A. Stevens, Vice President and General Manager, Health Policy and Strategic Reimbursement, PAREXEL Consulting, Lowell, MA

Under Construction: The Medicare Clinical Trial Policy

by Kathleen H. McGuan, Partner in the Life Sciences and Health Group of the law firm of Reed Smith, LLP, Washington, DC

Develop FDA Clinical Trials and Labeling with Payment in Mind
by John B. Reiss, Partner & Member of the Health Law and Life Sciences Practice Groups in the law firm of Saul Ewing LLP, Philadelphia, PA

Reimbursement Challenges with In Vitro Diagnostic Tests:
Fitting a Square Peg into a Round Hole
by Paul Radensky, Partner in the Health Law Department of the law firm of McDermott Will & Emery LLP, Miami, FL

Also In This Issue


Drug Price Controls in Canada: New Challenges and Opportunities for Manufacturers
by Wayne D. Critchley, Partner and Leader of the Drug Pricing & Reimbursement Group in the law firm of Gowling Lafleur Henderson LLP, Ottawa, Canada

and

Martin W. Mason, Partner and Senior Litigation Counsel of the Drug Pricing & Reimbursement Group in the law firm of Gowling Lafleur Henderson LLP, Ottawa, Canada

Three Strikes and You’re Out! Contractual Pitfalls in Medical Device Sales Agreements with Group Purchasing Organizations
by Derek E. Empie, Senior Associate, Health & Life Sciences Practice Group, Baker & Daniesl LLP, Indianapolis, IN

Update on Statutory Requirements for Handling Citizen Petitions Seeking
to Delay Generic Approvals

by Naomi Halpern, Partner in the law firm of Frommer Lawrence & Haug LLP, Washington, DC

“Voluntary” Guidance: How States Are Mandating Compliance with Federal
and Industry Guidance

by John Patrick Oroho, Partner at the law firm of Porzio, Bromberg & Newman, PC, Morristown, NJ

and

Sarina D. Rivera, Associate at the law firm of Porzio, Bromberg & Newman, PC,
Morristown, NJ

Columns


Enforcement Corner
Checking the Box Can Get You in the Hot Seat
by John R. Fleder, Principal in the law firm of Hyman, Phelps & McNamara, PC,
Washington, DC

Global Corner
Reimbursement in Europe: Health Technology Assessment and What the Future May Hold
by Matthew R. Weinberg, Chief Executive Officer, THE WEINBERG GROUP, Washington, DC

Canadian Corner
Bill in Parliament Proposes Changes to the Food and Drugs Act
by Brian Daley, Partner in the law firm of Ogilvy Renault in Montreal, Quebec, Canada

Associates’ Corner
Hatch Waxman Generic Drug Exclusivity Update: Forfeiture Woes
by Jay B. Sitlani, Associate in the law firm of Axinn, Veltrop & Harkrider LLP, Washington, DC


(Note: All author affiliations are current as of the date of publication of the issue.)

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