FDA Advertising and Promotion Manual
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Drug and device manufacturers face billions of dollars in fines, expensive continuing compliance scrutiny, massive adverse publicity and even the prospect of criminal charges, fines and imprisonment. Due to ongoing enforcement efforts, ensuring marketing and sales compliance is more important than ever. It is absolutely critical that your compliance efforts reflect the latest laws, regulations and settlement agreements, and integrate the latest strategies and techniques. Thompson’s FDA Advertising and Promotion Manual is designed to clarify the legal and regulatory complexities surrounding compliance, to keep you up to date on new activity at the federal and state level, and to provide expert insight and practical guidance that you can use to bolster your compliance policies and procedures.
With FDA Advertising and Promotion Manual, you can:
• Stay in compliance with key statues, regulations, guidance documents, federal agency advisory opinions, industry guidelines, settlement agreements, and more
• Assess your compliance programs, training procedures, and promotional pieces, including the challenges of off-label promotions
• Keep up-to-date with monthly updates and access to our subscriber-only website and our searchable database of more than 10,000 FDA enforcement letters
• Call the editor with unanswered questions — a special resource for subscribers
Drug and device manufacturers face billions of dollars in fines, expensive continuing compliance scrutiny, massive adverse publicity and even the prospect of criminal charges, fines and imprisonment. Due to ongoing enforcement efforts, ensuring marketing and sales compliance is more important than ever.
Thompson’s FDA Advertising and Promotion Manual explains Food and Drug Administration (FDA) and Federal Trade Commission (FTC) regulations and guidelines for the advertising and promotion of pharmaceuticals, medical devices, biologics, foods, veterinary medicines and cosmetics. The entire range of marketing vehicles is examined — the Internet, print ads, scientific symposia, television and radio ads, detailers, press releases, sponsored studies, celebrity endorsements, media tours and teleconferences. The Manual is designed to clarify the legal and regulatory complexities surrounding compliance. It will keep you up to date on new activity at the federal and state level, provide you with expert insight and practical guidance that you can use to bolster your compliance policies and procedures and keep your marketing efforts on track.
With the 12-month subscription to the FDA Advertising and Promotion Manual you’ll receive our two-volume Manual; monthly updates and newsletters; and so much more.
• Have not only the laws and regulations at your finger tips – but market analysis, and a breakdown of the specifics regulation sections and how they apply
• See the compliance implications of key statutes and regulations
• Be able to review federal agency advisory opinions, industry guidelines, settlement agreements and more
• Have expert insight into compliance procedures; pinpoint deficiencies in your company’s compliance and training
• Be able to develop a compliance program that reflects the latest OIG standards; be able to adequately review promotional pieces and programs; handle the unique compliance challenges of off-label promotion and misrepresentation of pricing information; and more
Order today – the right copy – makes all the difference!
- Two-volume manual
- Updates (12 updates)
About Your Subscription
Your annual subscription includes published updates at no additional charge for the 12 month subscription period. If you have any questions about your subscription, please contact Client Services at 800-677-3789 or by e-mailing email@example.com
Wayne L. Pines is an international consultant on regulatory strategy, media relations and crisis management. He has written 10 books about FDA and related issues. He currently is president of regulatory services and health care at APCO Worldwide in Washington, D.C. He served for 10 years at the FDA as chief of consumer education and information, chief of press relations and associate commissioner for public affairs. He has been on the board of public companies and non-profit organizations, and has been named by FDA as an alumnus of the year. Mr. Pines is co-author and editor-in-chief of the FDA Advertising and Promotion Manual.
Coleen Klasmeier is a partner in Sidley Austin LLP's Washington, D.C., office. Her practice focuses principally on sophisticated pharmaceutical regulatory and enforcement matters, beginning at the early stages of product investigation through regulatory review and into postmarketing. Before joining the firm in January 2005, she served as Special Assistant to the Chief Counsel of FDA. At FDA, she provided advice on the constitutional and statutory limitations on FDA authority and on policy matters to the Chief Counsel and to senior agency executives. She also focused heavily on the promotion of FDA-regulated products, the regulatory categorization of products, preemption of state product liability claims with respect to drugs and medical devices, and the relationship between FDA and the Securities and Exchange Commission. She is the co-author, with Wayne Pines, of the FDA Advertising and Promotion Manual. She also has chaired the Food and Drug Committee of the American Bar Association's administrative law section.
Editorial Advisory Board for the FDA Advertising & Promotion Manual
Wayne L. Pines
Editor in Chief
President, Regulatory Services & Healthcare
APCO Worldwide, Washington, D.C.
Partner, Sidley Austin LLP
Scott Bass, J.D.
Partner, Sidley Austin LLP
Alan Bennett, J.D.
Partner, Ropes & Gray LLP
Thomas A. Ghignone
Director, Legal Affairs
Sanofi Pasteur Inc.
David M. Hoffmeister
Partner, Wilson Sonsini Goodrich
Palo Alto, Calif.
John Kamp, Ph.D., J.D.
Executive Director, Coalition
for Healthcare Communication
New York, N.Y.
Geoffrey Levitt, J.D.
Senior Vice President and Associate General Counsel, Regulatory and Policy Law
New York, NY
Michael Misocky, R.Ph., J.D.
President, Misocky Consulting Group LLC
Lynn Shapiro Snyder, J.D.
National Health Law Practice Leader
Epstein Becker & Green, PC
Andrew J. Strenio, Jr.
Partner, Sidley Austin LLP
William M. Zoffer
Senior Vice President, Research & Development Legal Operation