FDLI Publication Previews
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- Off-Label Communications: A Guide to Sales & Marketing Compliance - 2nd Edition
- Biomedical Software Regulation
- Global Pharmacovigilance Laws & Regulations: The Essential Reference
- Nanotechnology & FDA-Regulated Products: The Essential Guide
- Food and Drug Law and Regulation
- A Practical Guide to Food and Drug Law and Regulation - 3rd Edition
- FDCA Statutory Supplement, including all the FDA Amendments Act of 2007
and Related Sections of Additional Statutes
Off-Label Communications:
A Guide to Sales & Marketing Compliance
(Second Edition)
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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.
This comprehensive guidebook provides practical advice on how
to comply with those regulations. This user-friendly resource includes a valuable historical perspective on off-label use and promotion, while providing practical instruction on how to deal with them. You’ll find detailed information on managing clinical trial disclosures; reimbursement; training and monitoring sales and marketing representatives; risk management; product liability litigation; ethical considerations and how the government is enforcing off-label sales and marketing compliance.
The second edition is significantly different from the first one, incorporating new developments that affect the regulation of sales and marketing practices as well as the corporate compliance activities that govern them.
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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Included in the preview of this publication:
- information about the book
- the first page of every chapter
PRICE
$129 Member | $169 Non-member
For academic pricing or bulk discounts, contact Customer Service, (202) 371-1420.
Published September 2009
Biomedical Software Regulation
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As health care professionals increasingly rely on biomedical software to help treat patients, it is also becomingly increasingly complex. This book describes how the federal government is regulating the software used in delivering healthcare to millions of Americans. This user-friendly guide summarizes the key regulations promulgated by the Food and Drug Administration and the Center for Medicare and Medicaid Services (CMS) and provides several key reference materials and documents for use by professionals in a variety of healthcare settings. This landmark book covers a wide range of topics, including FDA regulation of software as a medical device; software validation; medical imaging software regulation; electronic recordkeeping; software used in clinical trials; laboratory information management systems (LIMS); and HIPAA privacy rules and security standards.
Preview Available!
Included in the preview of this publication:
- table of contents
- information about the book
PRICE
$129 Member | $169 Non-member
For academic pricing or bulk discounts, contact Customer Service, (202) 371-1420.
Published April 2009
Global Pharmacovigilance Laws
& Regulations:The Essential Reference
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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.
Preview Available!
Included in the preview of this publication:
- table of contents
- information about the book
PRICE
$129 Member | $169 Non-member
For academic pricing or bulk discounts, contact Customer Service, (202) 371-1420.
Please click here to read the latest press release on this book.
Published April 2009
Nanotechnology & FDA-Regulated
Products: The Essential Guide
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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.
Preview Available!
Included in the preview of this publication:
- table of contents
- information about the book
PRICE
$99 Member | $129 Non-member
For academic pricing or bulk discounts, contact Customer Service, (202) 371-1420.
Published February 2009
Food and Drug Law and Regulation
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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.
Preview Available!
Included in the preview of this publication:
- table of contents
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PRICE
$279 Member | $329 Non-member
For academic pricing or bulk discounts, contact Customer Service, (202) 371-1420.
Published December 2008
A Practical Guide to Food and Drug
Law and Regulation - 3rd Edition
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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
Preview Available!
Included in the preview of this publication:
- table of contents
- introduction of the book
- first page of all 18 chapters
PRICE
$99 Member | $149 Non-member
Published 2008
FDCA Statutory Supplement, including
all the FDA Amendments Act of 2007 and Related Sections of Additional Statutes
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The FDCA Statutory Supplement incorporates all the latest revisions to the Food, Drug, and Cosmetic Act including the FDA Amendments Act of 2007. This comprehensive and fully integrated text is the most up-to-date version available, which is equally useful to both students and practitioners alike. A must for your bookshelf.
Preview Available!
Included in the preview of this publication:
- table of contents
PRICE
$79 Member | $99 Non-member
Published 2008