FDLI Publications - Monograph Volume 1, Number 4

FDLI Monograph Series
Volume 1, Number 4

International Prescription Product Recalls:
A Practical Guide
James M. Wood, Partner, Reed Smith LLP, San Francisco
Areta L. Kupchyk, Partner, Reed Smith LLP, Washington, DC

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Table of Contents, About this Monograph and the first page of chapters 1-3

About This Monograph

Ever faced an international recall?

Then you know what a daunting task it is to deal not only with myriad rules promulgated
by the U.S. Food and Drug Administration but also comparable (and sometimes
conflicting) monitoring and regulation by government entities in every country in which
you do business.

The diversity and complexity of laws, regulations, guidances and ordinances globally can
present unimaginable logistical nightmares for manufacturers — unless you’re completely
prepared to initiate a global recall when required.

This monograph — the fourth of six in Volume 1 — is the single, comprehensive resource
you need to be totally prepared:

You’ll find user-friendly summaries of the varying recall requirements of the World
Health Organization, European Medicines Agency and Health Protection Branch of
Health Canada.
You’ll get a handy checklist of what to put in your recall binder to make sure you’re
not caught short if you face a recall.
And you’ll find a practical, proactive plan for your company that includes an
invaluable listing of do’s and don’ts.

The bottom line—this monograph enables you to:

Understand the complex and varying requirements of international bodies that
regulate prescription products;
Create a proactive model that will serve as a minimum threshold for conducting
an international recall; and
Implement an electronic notebook that can serve as an invaluable resource for your
company when faced with an international recall.

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FDLI Monograph Series Volume 1, Number 4