Resources & Books for Students - Food and Drug Law Institute

Resources & Books
for Students
The Food and Drug Law Institute

THE FOOD AND DRUG LAW INSTITUTE | ACADEMIC CATALOG 2012
TABLE OF CONTENTS
Membership Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Texts for Legal and Regulatory Courses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
How to Order . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Publication Order Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Membership Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
www.fdli.org

THE FOOD AND DRUG LAW INSTITUTE | ACADEMIC CATALOG 2012
Membership Opportunities
Students (full-time only): Annual Dues $25
Reserved for full-time students enrolled at a college or university. An individual employed by an organization
eligible for FDLI corporate membership may not join as a student. Students must submit a copy of their current
class schedule and member application (see pages 6–7) to MembDept@fdli.org.
Important Benefits for Student Members:
Resume Building — Writing Opportunities — Education & Networking
For more than 60 years, the Food and Drug Law Institute (FDLI) has been a membership organization committed to
providing education through publications, conferences and networking opportunities to the entire food and drug
law community.
Highlight FDLI Membership on your Resume
FDLI is the most trusted and well know Institute within the food and drug law community with thousands of
engaged members and affiliates.
H. Thomas Austern Memorial Writing Competitions — Get Published
1st place: $4,000 and 2nd place: $1,000
FDLI sponsors this yearly writing competition for law students interested in the food and drug law. Winning papers
will be considered for publication in FDLI’s award-winning, peer reviewed Food and Drug Law Journal. There are
two competitions — one for papers with a maximum of 40 pages, and one for papers between 41 and 100 pages.
FDLI Update Magazine — Writing Opportunity and Complimentary Subscription with Student Membership
Published bi-monthly and circulated to more than 6,500 industry professionals, Update, brings you the latest
news from FDLI and the food and drug law community, featuring viewpoints on industry-specific trends, articles
on varied topics of regulatory concern, changes at FDA, and more. There is a featured column, Student Corner,
dedicated to student members who have an interest in writing for the publication.
Networking and Educational Opportunities — Student Members Receive Discounts
FDLI holds more than 30 conferences each year and students have their own deeply discounted registration rates.
FDLI’s Annual Conference, held every spring in Washington DC, is the largest and longest-running conference for
professionals interested in regulation and policy in the food and drug law industry. The Conference provides a
valuable educational opportunity and a central venue to discuss and debate emerging issues while networking
with future colleagues.
In addition to conferences, student members receive discounts (Books, Primers, Journal articles) or
complimentary access (Policy Forum, Update magazine) to more than 50 publications each year.
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Snapshot of Benefits:
• At least a 20% discount on conferences and
publications, with additional special rates
and discounts
• Invitation to participate in FDLI's annual
Writing Awards Competition
• Receive daily and weekly legislative and
regulatory information
• Online access to Update magazine (bi-monthly)
• Speaking, writing and business development
opportunities
• Opportunity to submit policy papers and special
reports for publication
• Opportunity to serve on FDLI Committees
• Online access to FDLI's Food and Drug Policy Forum
• Invitations to members-only events
www.fdli.org

T
THE FOOD AND DRUG LAW INSTITUTE
Texts for Legal and Regulatory Courses
A Practical Guide to FDA's Food and Drug Law and Regulation, 4th Edition
The Fourth Edition of A Practical Guide to FDA's Food and Drug Law and Regulation updates
and expands the widely-used Third Edition, including coverage of new laws on biosimilars,
tobacco and food safety. A Practical Guide remains the single best resource for both
practitioners and academics needing a basic, easy-to-use overview of the many laws and
regulations administered and enforced by the Food and Drug Administration. This book
A Practical Guide to
FDA’s Food and Drug
Law and Regulation
Fourth Edition
Edited by Kenneth R. Piña and Wayne L. Pines
encompasses food and drug law, beginning with a historical background, philosophy, and
organization of food and drug law and how it works. Other chapters include information about
combination products, dietary supplements and inspections. The goal of this fourth edition
of A Practical Guide to FDA's Food and Drug Law and Regulation is to explain the law and
regulations that govern the development, marketing, and sale of food, medical products, and
cosmetics in simple, nontechnical terms.
Special price available for student members: $119.00
Author: Kenneth R. Piña and Wayne L. Pines, Editors
Cover: Softcover
Number of pages: 521 pages
Edition: Fourth Ed. Date published: Apr 30, 2012
ISBN: 156-978-1-93065-4-0
Language: English
Food and Drug Law and Regulation, 2nd Edition
FOOD AND DRUG
LAW AND
REGULATION
SECOND EDITION
FOOD AND DRUG LAW
AND REGULATION
SECOND EDITION
Food and Drug Law and Regulation is one of the most comprehensive guidebooks ever
published covering an area that accounts for more than 25 percent of all consumer
spending in the United States.
978-1-935065-44-9
ADAMS
COOPER
HAHN
KAHAN
EDITED BY
DAVID G. ADAMS
RICHARD M. COOPER
MARTIN J. HAHN
JONATHAN S. KAHAN
Equally relevant to practicing food and drug attorneys; in-house drug, device, biologics,
cosmetics, food and tobacco counsel; consultants; law professors and students, this
unique, 27-chapter resource includes more than a dozen chapters on the Food and Drug
Administration’s vast and complex regulatory systems and standards — everything from
food safety to prescription drug promotion to combination products. It includes invaluable
information on FDA’s administrative and enforcement authority as well as the agency’s role in
addressing bioterrorism, international issues and the practice of medicine. This resource also
contains the latest must-have information on DEA’s regulation of controlled substances, FTC’s regulation of advertising and
CMS’s federal reimbursement for medical products. This new second edition updates all topics from the 2008 edition and
adds new chapters on FSMA, Tobacco and Biosimilars.
Special price available for student members: $159.00
Author: David G. Adams, Richard M. Cooper, Martin J. Hahn & Jonathan S. Kahan, Editors
Cover: Hardcover
Number of pages: 1,032 pages
Edition: Second Ed. Date published: Dec 31, 2011
ISBN: 978-1-935065-44-9
Language: English
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Institute
shington, DC 20005
371-0649
-42-5
CD Included
ACADEMIC CATALOG 2012
Texts for Legal and Regulatory Courses Cont.
FDCA Statutory Supplement 2011, Second Edition
This new 2011 second edition fully integrates the food safety provisions added and
changed in the Food, Drug and Cosmetic Act by the Food Safety Modernization Act as
FDCA Statutory Supplement, 2011, Second Edition
FDCA Statutory Supplement, 2011, Second Edition
New Edition Coming Soon
Edited by Joy J. Liu, Esq.
well as amendments made to the FDCA by the Patient Protection and Affordable Care
Act of 2010. This new edition presents a seamless version of all relevant changes in one
volume. Let FDLI do the work for you — Purchase this edition now and avoid spending
countless hours trying to piece together the landmark changes to FDCA. FDLI's bestselling
Statutory Supplement is your handy go-to source for the exact text of the current FDCA.
This new edition includes a CD with the entire volume in electronic format for greater
accessibility.
Special price available for student members: $159.00
Author: Joy J. Liu, Esq.
Cover: Softcover
Number of pages: 477 pages
Edition: Second Ed. Date published: Jun 27, 2011
ISBN: 978-1-935065-42-5
Language: English
FDCA Statutory Supplement and Compilation Combination
This second edition of the 2011 FDCA Statutory Supplement incorporates
amendments made by the passage of the Food Safety Modernization Act in
December 2010 as well as amendments made by the Patient Protection and
Affordable Care Act of 2010. For the first time, these changes are fully-integrated to
provide users one seamless, timely and accurate legal resource. For any food and
drug lawyer or other individual referring to the FDCA and related statutes, this book
is a must-have desk reference. This new edition includes a CD with the entire volume
in electronic format. Compilation of FDCA-Related Food and Drug Laws, 2010
includes the latest provisions of statutes related to the omnibus Food, Drug, and
Cosmetic Act, including those involving regulation of food and medical products,
commerce, enforcement activity and administrative law. For practicing attorneys and academics, this is a one-stop resource
for finding FDCA-related statutory provisions.
Special price available for student members: $189.00
Author: Joy J. Liu, Esq. and Deborah M. Shelton, Editors
Cover: Softcover
Edition: Second Ed.
Date published: Sep 15, 2010 Language: English
Kit Products: Compilation of FDCA-Related Food and Drug Laws, 2010 Edition,
FDCA Statutory Supplement 2011, Second Edition
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THE FOOD AND DRUG LAW INSTITUTE | ACADEMIC CATALOG 2012
How to Order
Student Members
• Email or fax Customer Service, service@fdli.org, 202-371-0649, the attached order form
and your membership application (if not already a member).
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Bulk Pricing
• 5–19 copies: Save 10%
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Email Michael Sprott, FDLI’s Customer Service Manager, at mms@fdli.org for more information.
Bulk orders may exceed our standard shipping and handling charges. If this occurs, additional payment will be required.
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The Food and Drug Law Institute
Membership Application
FDLI membership is available to professionals with interests in food, drugs, animal drugs, biologics, cosmetics,
diagnostics, dietary supplements, medical devices and tobacco.
Membership Categories
FDLI membership is available to corporations and individuals. If you are employed by a company eligible for “Corporate Membership,” you are not
eligible for “Individual Membership.”
Corporate Memberships
Manufacturers
Manufacturer dues are based on the company’s previous fiscal year’s sales,
defined as sales resulting from the manufacture of FDA- or USDA- regulated
products.
Start-up Manufacturer (no sales) .................................................. $1,050
Sales less than $100 million ......................................................... $2,075
Sales $100 – $500 million............................................................ $4,125
Sales $500 million – $1 billion .................................................... $7,000
Sales $1 – $10 billion ................................................................. $10,500
Sales more than $10 billion ........................................................ $12,500
Contract Manufacturers, Suppliers and Distributers
Contract Manufacturer (organization that makes products under contract for
other companies), Supplier and Distributor dues are based on the company’s
previous fiscal year’s sales, defined as sales resulting from the manufacture
and/or distribution of FDA- or USDA-regulated products.
Sales less than $100 million ......................................................... $2,000
Sales $100 – 500 million.............................................................. $3,000
Sales $500 million – 1 billion ...................................................... $4,000
Sales more than $1 billion ............................................................ $5,000
Law Firms
Please check this box if you would like to have your attorneys listed in the
online Professional Services Directory
Law firms ..................................................................................... $5,000
Service Organizations
Service Organizations include consulting firms, contract research
organizations, academic research organizations, academic health centers,
professional service groups, marketing and public relations firms, or any
other business providing professional services to regulated industry.
Please check this box if you would like to have your contacts listed in the online
Professional Services Directory
Service Organizations ................................................................... $2,500
Associations, Policy Institutions and Public Interest Groups
Associations, policy institutions (think tanks) and public interest groups
whose interest and/or constituency includes anything related to the regulation
of food, medical products, dietary supplements, cosmetics, tobacco.
Associations, Policy Institutions and Public Interest Groups ......................$750
Individual Memberships
Sole Practitioner Attorney or Consultant
Self-employed individuals providing legal or consulting services to professionals
in the field of food and drug law. An individual who is a full-time employee of an
entity that is eligible for FDLI membership as a Law Firm or Professional Service
Organization may become an FDLI member as a sole practitioner provided that
the individual is the only member of the organization engaged in the field of
food and drug law.
Please check this box if you would like to be listed in the online Professional
Services Directory
Sole Practitioner Attorney or Consultant .........................................$500
Academic
Full-time faculty members at institutions of higher education, who teach,
conduct research or publish in the field of food and drug law. Adjunct faculty
are included in the definition only if they are not also employed by an entity
eligible for FDLI corporate membership, such as a manufacturer, law firm or
service organization.
Academic ........................................................................................$175
Government Employees
Full-time employees of a federal, state, local, or foreign government agency
engaged in the regulation of food, medical products, dietary supplements,
cosmetics, tobacco.
Government Employees .....................................................................$45
Student
Reserved for full-time students enrolled at a college or university. An individual
employed by an organization eligible for FDLI corporate membership may
not join as a student. Students must submit a copy of their current class
schedule to MembDept@fdli.org.
Student ..............................................................................................$25
Emeritus Membership
FDLI continues to recognize the service and dedication of many professionals
in the food and drug law community. Emeritus membership is reserved for any
individual who is retired from their respective profession who wants to continue
involvement with the food and drug law community and support the Institute.
Lifetime Membership (one-time dues payment)...............................$500
FDLI is a 501(c)(3) non-profit educational organization and is a public charity. For federal income tax purposes, dues (less the value attributed to subscriptions and discounts)
may be deductible as a charitable contribution. Please refer to the FDLI website (http://www.fdli.org/memb/categories.html) for guidance on the amount which may be
considered a tax deductible contribution.
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FOOD | DRUGS | ANIMAL DRUGS | BIOLOGICS | COSMETICS | DIAGNOSTICS | DIETARY SUPPLEMENTS | MEDICAL DEVICES | TOBACCO

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Membership Application Application (Submit (Continued)
this page only)
1
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Fax completed application to:
FDLI, 1155 15th St. NW Suite 800
(202) 371-0649
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Primary Contact (First, Last)
Job Title
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Assistant’s Name
Email
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Additional Company Contacts (For Corporate Members Only)
If you need more space, feel free to include more contacts in a list along with the membership application, or email the list to MembDept@fdli.org.
All contacts listed will receive the FDLI member magazine Update and all other membership benefits.
Send membership invoices to:
Name Job Title Email Phone
Send member copy of the Food and Drug Law Journal to:
Name Job Title Email Phone
Additional Company Contacts (i.e. Legal, Regulatory, Compliance):
Name Job Title Email Phone
Name Job Title Email Phone
Name Job Title Email Phone
Interest Areas:
Animal Health Products Biologics Cosmetics Diagnostics Dietary Supplements Drugs
Food/Food Additives Medical Devices Tobacco
How did you hear about us?
FDLI’s Website FDLI SmartBrief Web Search Email Mailed Brochure Update Magazine FDLI Meeting Colleague
Twitter LinkedIn Facebook Other ______________________
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By signing below, I certify that the information included in this application is true and complete to the extent of my knowledge. This application will be
complete only when the above information and payment in the appropriate amount have been received by FDLI. Membership dues are non-refundable.
APPLICANT SIGNATURE
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