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Issue 3 : May/June 2009


FDA: Full House?
May/June 2009

Subscription Information

FDLI members receive Update as part of membership.
Additional copies or back issues are available at $15 each.

 

 


Articles


Navigating Privilege Issues

by Jessica Miller, Partner with the law firm of O’Melveny & Myers LLP, Washington, DC

and

Nina Ramos, Associate with the law firm of O’Melveny & Myers LLP, Washington, DC


Beware the Changing Face of Compliance for the Medical Devices Industry in Europe

by Alison Dennis, Partner in the law firm of Field Fisher Waterhouse LLP, London, England


“Otherwise Unfit for Food”: A Modern Food Safety Tool?

by Fred H. Degnan, Partner in the law firm of King & Spalding, LLP, Washington, DC

and

Liana R. Grossman, Associate in the law firm of Goodwin Procter, LLP, New York, NY


State Regulation of Medical Device Distribution: Strategic Planning Needed
to Address Varying Requirements

by M. Elizabeth Bierman, Partner in the law firm of Morgan, Lewis & Bockius, LLP, Washington, DC

and

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


Implications of Congressional Food Safety Reform: Getting Ahead of the Regulatory Curve

by Paul D. Rubin, Partner in the law firm of Patton Boggs LLP, Washington, DC

and

Jean E. McCue, Associate in the law firm of Patton Boggs LLP, Washington, DC


China
Drug and Device Regulatory Update 2009
by Ames Gross, President and Founder of Pacific Bridge Medical, Bethesda, MD

and

John Minot, Associate at Pacific Bridge Medical, Bethesda, MD

Exclusivity Strategies in the United States and European Union
by Carolyne Hathaway, Partner in the law firm of Latham & Watkins, Washington, DC

and

John Manthei, Partner in the law firm of Latham & Watkins, Washington, DC

and

Cassie Scherer, Associate in the law firm of Latham & Watkins, Washington, DC


Sales Rep Nightmares: Emerging Issues in Marketing Compliance

by John Patrick Oroho, Principal in the law firm of Porzio, Bromberg & Newman PC and Executive Vice President with Porzio Pharmaceutical Services, LLC, Morristown, NJ

and

Christine N. Bradshaw, Associate in the law firm of Porzio, Bromberg & Newman PC and Manager of Regulatory and Compliance Services with Porzio Pharmaceutical Services, LLC, Morristown, NJ

and

Christopher R. Corallo, Compliance Audit Associate with Biomet, Parsippany, NJ and former Senior Regulatory Analyst with Porzio Pharmaceutical Services, LLC, Morristown, NJ



Columns


Enforcement Corner

Search Warrants―What Happens When the FDA Storm Arrives
by John R. Fleder, Principal in the law firm of Hyman, Phelps & McNamara, PC,
Washington, DC


Global Corner
Registering Orphan Drugs in the EU
by Matthew R. Weinberg, Chief Executive Officer, The Weinberg Group, Washington, DC


Canadian Corner

Professional Allowance Payments by Drug Manufacturers to Pharmacists:
The “Rebate” Alternative

by Brian Daley, Partner in the law firm of Ogilvy Renault in Montreal, Quebec, Canada

and

Kristin Wall, Associate in the law firm of Ogilvy Renault in Toronto, Ontario, Canada


Students Corner
Incentives for Innovation: A Call for Geriatric Exclusivity Legislation
by Taylor Pierce, JD/MPH Candidate, the University of Minnesota


Associates’ Corner

Biosimilars Legislation
by Joy J. Liu, Associate in the law firm of Ropes & Gray LLP, Washington, DC


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

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