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Issue 1 : January/February 2002

 

Update 2002, Issue 1: Government Enforcement of GMPs and Consent Decrees

 

 

Government Enforcement of GMPs
and Consent Decrees

January/February 2002

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

 

 

 

Feature Articles


Turning a Consent Decree Into a Success

by Ron Johnson, Executive Vice President of Quintiles Consulting, Rockville, MD

When CGMPs Become "TMPs" . . .
by Douglas B. Farquhar, Partner in the law firm of Hyman, Phelps & McNamara P.C., Washington, D.C.

Compliance: Benefit vs. Burden
by Matthew Weinberg, Chief Executive Officer of THE WEINBERG GROUP INC., Washington, D.C.

 

Also In This Issue


Preparing for and Surviving FDA Inspections

by Frederick H. Branding, R.Ph., J.D., Member of the law firm of Bell, Boyd & Lloyd, LLC, with offices in Chicago, IL and Washington, D.C.

The Current State of Stem Cell Research in the United States
by James M. Wood, Partner in the law firm Crosby Heafey, Oakland, CA

HIPAA Considerations for Pharmaceutical Industry-Sponsored Research
by Michele B. Gerroir and Lauren A. Sullivan, Associates with the law firm of Wiggin & Dana LLP, New Haven, CT

USDA's National Organic Program: The Final Rule
by Leslie T. Krasny, Partner in the law firm of Keller and Heckman LLP, San Francisco, CA

Sustainable Innovation for Public Health
by Michael A. Gollin, Attorney with the law firm of Venable, Baetjer, Howard & Civiletti, LLP, Washington, D.C.

FDA on Patrol at Medical Meetings: New Trend or New Turf?
by Michael A. Misocky, Associate Director, Regulatory Services, at Bristol-Myers Squibb, Plainsboro, NJ

 

Columns


Making History

The Center for Science in the Public Interest Celebrates Its 30th Anniversary
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration, Rockville, MD

Enforcement Corner
The TAP Prosecution: Taking Enforcement to a New Level
by Steven M. Kowal, Partner in the law firm of Bell, Boyd & Lloyd, Chicago, IL

Global Corner
Compliance: A Lesson on Focus
by Robert A. Rhoades, Managing Consultant with THE WEINBERG GROUP INC., Washington, D.C.

Associate's Corner
A Future for Generic Biologics?
by Jennifer J. Spokes, Attorney in the law firm of Patton Boggs LLP, Washington, D.C.

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

 

 

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

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