BOOKS AND WHITE PAPERS
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(Integrating revisions to FDCA and BLA licensing provisions of PHSA, including Menu Labeling provisions, Biosimilars Pathway and related Patent Act changes made by Patient Protection and Affordable Care Act)
Edited by Deborah M. Shelton, Esq. and Kathryn E. Dobson, Ph.D.
A preview of this publication will be available soon!
This new 2010 edition integrates the bisomilars pathway and menu labeling provisions contained in the Patient Protection and Affordable Care Act and other FDCA-related provisions enacted by Congress. This new edition shows you exactly the important (and numerous) changes to FDCA and PHSA by PPACA. Let FDLI do the work for you — Purchase this edition now and avoid to spending countless hours trying to piece together the landmark changes to FDCA.
As always, FDLI's bestselling Statutory Supplement is your handy go-to source for the exact text of the current FDCA. This new edition includes a complimentary CD with the entire volume in electronic format for greater accessibility. The changes made by the PPACA to the FDCA and selected portions of the PHSA are carefully noted for you in the second edition. New text is italicized and deletions are noted in strikethrough, so you can see at a glance how Congress used the healthcare law to change the FDCA. FDLI has already integrated these important changes for you into one easy-to-use volume, savings you hours and hours of work.
Also available in combination with Compilation of FDCA-Related Food and Drug Laws, 2010.
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Published September 2010
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Edited by Carrie Dooher, Esq.
A preview of this publication will be available soon!
Twitter. Facebook. Blogs. They're here, and they're not going
away, ever. Ever.
Yes, like it or not, social media tools are becoming part of the basic fabric of the foods and medical products industry.
- Are you up-to-speed on how government agencies intend to monitor the use of social media by industry?
- Is your organization utilizing state-of-the-art social media tools?
- Are you a little confused about your next move in this area?
Not to worry. The Food and Drug Law Institute has published the first comprehensive guidebook on the use of social media in the food and medical products areas. This landmark book, Using Social Media in FDA-Regulated Industries: The Essential Guide, includes must-read chapters on all aspects on social media, including:
- How FDA uses social media to reach consumers and rapidly expanding use of social media
by regulated industry;
- Why pharmaceutical firms need to pay particularly close attention to social media
of existing and new drugs;
- How current FTC regulation of advertising indicates the way in which FTC will regulate
social media advertising;
- How patient advocacy groupsare changing the playing field using social media;
- Why the First Amendment can offer protection against regulators — sometimes;
- Why PhRMA says that FDA needs to allow medical product companies to utilize new
and social media more often and more effectively; and
- How communications and public relations campaigns can capitalize on social media
tools to increase your ROI.
Published September 2010
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$129 Members | $179 Non-Members
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Edited by Stephen D. Terman and Neil F. O'Flaherty
A preview of this publication is available here. Included in the preview:
- Table of contents
- First page of every chapter
- First page of every appendix
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This practical guidebook is one of the most comprehensive resources published in the often complicated field of medical device regulation and compliance. FDA has made it clear that it intends to be increasingly vigilant in monitoring medical device compliance. For example, the agency will be implementing a more rigorous regulatory approach for device recalls when there is evidence that the device presents a potential or actual serious risk to health.
This book addresses medical device labeling, quality system regulation, complaint handling, recalls, tracking and postmarket surveillance.
The authors who contributed to this book have decades of experience advising clients on medical device law, regulation and compliance issues.
Simply put, if you're looking for a single resource on medical device regulation and compliance, this book is designed to meet that need.
Published May 2010
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$149 Members | $199 Non-Members
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Edited by Scott D. Danzis and Ellen J. Flannery
A preview of this publication is available here. Included in the preview:
- Table of contents
- First page of every chapter
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This practical guidebook is the most comprehensive resource published on the burgeoning field of in vitro diagnostics, which increasingly occupies a central place in our healthcare system. Companies are investing great sums to develop and commercialize innovative diagnostic devices. Yet, the legal requirements surrounding IVD remain, in many ways, opaque.
This book brings together all of the disparate sources of information that inform our regulatory system on this often controversial issue. While the primary focus of this book is to describe in detail and in user-friendly terms, the regulatory requirements for IVDs, it does not shy away from the thorny public policy issues.
The authors who contributed to this guidebook have decades of experience advising IVD manufacturers and clinical laboratories, working with or in regulatory agencies and helping to bring innovative IVD devices and diagnostic tests to the market. Simply put, if you're looking for that single resource on IVD regulation and policy, this book is designed to meet that need.
Published April 2010
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$169 Members | $199 Non-Members
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Edited by John B. Reiss
A preview of this publication is available here. Included in the preview:
- Preface
- Chapter 1: Ashcroft v. Iqbal, pages 1-4
- First page of Chapter 22: Key 2009 Settlements in the Life Sciences Industry
- First page of Chapter 23: Food and Drug Administration Activities
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Are you familiar with Ashcroft v. Iqbal?
It's a Supreme Court decision involving "plausible claims" that's being increasingly cited in pharmaceutical and medical device litigation to help courts determine whether to grant motions to dismiss.
And it's just the first of 20 cases decided in 2009 that are discussed and analyzed by a wide array of legal experts from the practicing bar, Food and Drug Administration and academia in FDLI's new groundbreaking book, Top 20 Food and Drug Cases, 2009 & Cases to Watch, 2010.
The Top 20 list tells you everything you need to know about why the case is important and how it affects food and drug law detailing:
- Why the Case Made the List
- Facts of Case
- Why and How Court Ruled
- Rationale for Decision
- Current & Future Impact of Ruling
In addition, the book includes cases to watch in 2010, significant settlements in the food and drug area, and key actions taken by the Food and Drug Administration in 2009.
This book provides practitioners with the most comprehensive discussion and analysis of the important court rulings and administrative actions in the food and medical products area in the last 12 months, provided by long-standing legal experts. If you want one resource that will provide the assurance you're looking for that you're current on food and drug litigation, settlements and administrative actions, then Top 20 Cases is the book you need.
You'll want to take a close look at how these cases fit in with what's now on FDA's agenda. For example, what case represents the "opening salvo in what is certain to be lengthy and hard-fought legal battle over (expected) Food and Drug Administration regulation"? And what's the impact of the Wyeth v. Levine decision on FDA (and regulatory science)?
Because this 376-page book is published in hardback, quantities are limited. Don't miss your opportunity to have this invaluable resource on your bookshelf or in your library.
Published April 2010
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$249 Members | $279 Non-Members
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(Including Statutes Relating to Food and Medical Products; Regulation of Commerce; Enforcement and Criminal Sanctions; and Administrative Law)
Edited by Deborah M. Shelton, Esq. and Prof. Ralph F. Hall
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This valuable resource 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.
Also available in combination with FDCA Statutory Supplement, 2010, 2nd Edition.
Learn more about purchasing the set.
Published April 2010
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$129 Members | $159 Non-Members
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Edited by Mark Carlisle Levy
A preview of this publication is available here. Included in the preview:
- Information about the book
- First page of every chapter
- Preview Now
If you have an off-label issue you're dealing with, you're not alone.
Why? Because drugs, biologics and devices increasingly are used to treat patients in ways that were not specifically approved by FDA. And while FDA does not regulate off-label use nor forbid off-label prescribing, it does heavily regulate off-label promotion.
The second edition features these updates:
- FDA released its Final Guidance on Good Reprint Practices in January 2009. This much anticipated final document identifi es acceptable methods of dissemination of reference publications that may fall within a safe harbor from criminal prosecution.
- Since September 2008, Cephalon ($413 million), Eli Lilly ($1.4 billion) and Pfizer ($2.3 billion) have agreed to settle claims made by the federal government and several state attorneys general that each company promoted one of its drugs for off-label use.
- President Obama signed into law the Fraud Enforcement and Recovery Act (FERA) which revises the civil liability provisions of the False Claims Act. These revisions will significantly expand the scope of the FCA, enabling the government and qui tam relators to pursue wrongdoing related to a federal program, regardless of whether there is actually a false claim made to the government.
- The United States Supreme Court in Wyeth v. Levine rejected arguments that the doctrine of federal preemption shields a pharmaceutical manufacturer from state tort claims.
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$129 Members | $169 Non-Members
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Published September 2009
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Edited by Stephen L. Klincewicz, Yuung Yuung Yap, Adrian Thomas with Jami L. Taylor
A preview of this publication is available here. Included in the preview:
- Table of Contents
- Information about the book
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"This book provides an important side-by-side view of the pharmacovigilance systems of nations around the world. It stands to be a valuable resource for lawmakers, agencies, advocates, companies and others entrusted with the vitally important work of protecting public health." -- Senator Orrin G. Hatch
The international pharmacovigilance arena has become increasingly complex as emerging markets recognize the need to develop robust regulatory frameworks, while developed markets continue to grapple with the need to improve postmarketing risk management and ensure the safety of medicinal products.
Despite the recognition of the need for greater harmonization of pharmacovigilance requirements worldwide, regulatory requirements continue to diverge, resulting in significant differences in approaches to medicinal product safety.
This groundbreaking book details the pharmacovigilance systems of more than a dozen countries, and, for the first time, systematically analyzes the current state of pharmacovigilance from the perspective of practicing attorneys in every region of the world. Organized with careful attention to the unique aspects of each country's legal system and regulatory structure, this landmark guide is an essential reference for practicing attorneys, pharmacovigilance specialists, health officials, consultants and other professionals in the postmarketing surveillance field.
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Published April 2009
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A preview of this publication is available here. Included in the preview:
- Table of Contents
- Information about the book
- Preview Now
This book is a comprehensive guide on the law, regulation and policy pertaining to FDA-regulated products involving nanotechnology. Designed for product development and regulatory specialists at both nanotech firms and drug, device and food companies, this practical guidebook provides straightforward chapters on the science of nanotechnology and the legislative and regulatory framework of this rapidly growing technology. The book provides expert analysis of current and potential FDA regulation of nanotech products, EPA oversight activities, risk management considerations and policy and ethics concerns involving nanotechnology.
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$99 Members | $129 Non-Members
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Published February 2009
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Edited by David G. Adams, Richard M. Cooper, Martin J. Hahn
and Jonathan S. Kahan
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Written by the most experienced food and drug attorneys in the United States and edited by four of the most distinguished authorities in the field, Food and Drug Law and Regulation is one of the most comprehensive guidebooks ever published covering an area that accounts for more than 20 percent of all consumer spending in the United States.
This definitive manual is the ultimate resource tool on food and drug law, presenting penetrating analysis, explanation and discussion of virtually all aspects of food and drug law and regulation. Each chapter includes extensive legal citations, which will expedite your legal analysis and research.
Equally relevant to practicing food and drug attorneys, in-house drug, device, biologics, cosmetics and food counsel, regulatory professionals, consultants, law professors and students, this unique, 25-chapter treatise 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. The book 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. The book 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 hardbound book is destined to become the most utilized legal and regulatory reference source in the food and drug community.
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$279 Members | $329 Non-Members
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Published December 2008
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Edited by Kenneth R. Piña and Wayne L. Pines
A preview of this publication is available here. Included in the preview:
- Table of Contents
- Introduction of the book
- First page of all 18 chapters
- Preview Now
The Third Edition of A Practical Guide to Food and Drug Law and Regulation has been significantly updated and revised from the Second Edition, including incorporation of the Food and Drug Administration Amendments Act and other new laws passed since 2002. It also includes three new chapters: Combination Products, Pharmacovigilance and Regulation of Medical Research. A Practical Guide remains the single best resource for anyone needing a basic, uncomplicated understanding of the myriad requirements enforced by the Food and Drug Administration.
"'A Practical Guide' has served for many years as an outstanding primary resource for those who need a basic, plain language explanation of the laws and regulations affecting FDA-regulated products. The book should be required reading for anyone entering a company whose products are regulated by FDA, for law school students or for experienced lawyers, regulatory affairs practitioners, and consultants who want a clear explanation of the basis of FDA regulation." -- Alan Bennett, Managing Partner, Ropes and Gray
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$99 Members | $149 Non-Members
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Published 2008
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Bringing Your Medical Device to Market, 2nd Edition
Medical device and other healthcare product manufacturers are among the most heavily regulated markets in the United States economy. While this book focuses on medical devices, most of the book is equally applicable to biologics, pharmaceuticals or other medical products, except for specific FDA requirements.
In this new edition, a number of chapters have been added by authors from Exponent, a consulting firm that helps clients with challenging engineering and related scientific problems including those involving medical devices, and with the initial preparations for designing, developing, and manufacturing such products.
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$129 Members | $179 Non-Members
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FDLI Colloquium Series Transcript #3:
Communicating Risk Safety Information
This meeting was the third in a series of colloquia sponsored by FDLI. Under its new strategic direction, FDLI is committed to using the Colloquium series as a neutral forum to address the legal, regulatory, policy and practical implications of technological innovations affecting the food and drug industry.
As the public becomes more concerned about whether it's safe to take — or stop — their medications, FDA is making risk communication a top priority. The agency is forming an advisory committee on communication and implementing new Congressional requirements on risk evaluation. But it's unclear what that means for those who must deal with adverse events and contraindications every day.
Speakers:
- Janet Woodcock, Deputy Commissioner & Chief Medical Officer, FDA;
- Randall W, Lutter, Deputy Commissioner for Policy & Planning, FDA;
- Stuart M. Pape, Managing Partner, Patton Boggs;
- Robert Dormer, Partner, Hyman Phelps & McNamara;
- Grace-Marie Turner, President, Galen Institute;
- Susan Newberry, Senior Vice President, Director, D.C Healthcare Practice, Ketchum Communications;
- Kelly Posner, Associate Professor, Columbia University.
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$49 Members | $99 Non-Members
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Published January 2008
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FDLI White Paper #2: Transcript:
From Abigail to Pelelope: Individual vs. Corporate Rights
Find out what these experts had to say about access to unapproved drugs for seriously ill patients:
- Janet Woodcock, MD, Deputy Commissioner and Chief Medical Officer
at the Food and Drug Administration
- Scott Ballenger, a partner at Latham & Watkins in Washington, D.C.,
and lead attorney in the Abigail Alliance case
- D. Bruce Burlington, MD, Executive Vice President of Business Practices
and Compliance at Wyeth Pharmaceuticals
- John Crowley, President and Chief Executive Officer at Amicus Therapeutics
- Philip Katz, a partner at Hogan & Hartson in Washington, D.C.
- Jonathan Moreno, an ethics professor at the University of Pennsylvania
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Published January 2008
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FDLI Colloquium Series White Paper #1:
Whose Life Is It, Anyway? Abigail Alliance at the Crossroads
A tough question - but one that FDA, pharmaceutical manufacturers, physicians, patients and the courts now are urgently trying to answer. FDA has proposed rules that will make it easier for dying patients to get access to drugs still undergoing clinical trials. And the U.S. Court of Appeals for the D.C. Circuit is revisiting its landmark decision in Abigail Alliance v. von Eschenbach.
So, how will this issue affect you? You can find out with a copy of this White Paper, published by FDLI as part of its Colloquium Series on important issues affecting the food and drug industry. The White Paper includes insightful articles by Scott Ballenger, who represents Abigail Alliance; Richard Cooper, former FDA general counsel; Scott Gottlieb, former FDA Deputy Commissioner for Medical and Scientific Affairs; nationally recognized ethicist Arthur Caplan; litigator Mark Gately; pharmacist Frank Polumbo and David Welch, founder of 38 Lemon, an organization promoting brain cancer awareness from a patient's perspective.
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$95 Members | $125 Non-Members
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Published January 2008
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