Thompson FDA

FDA Advertising and Promotion Manual

Avoid missteps surrounding federal advertising and promotion requirements for drugs, medical devices, biological products, foods and veterinary products.

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$767.00 FDA Advertising and Promotion Manual (Online)

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$899.00 plus $37.99 S&H


$899.00 FDA Advertising and Promotion Manual (Print)

Dual (Online + Print)
$1157.00 plus $37.99 S&H


$1157.00 FDA Advertising and Promotion Manual (Online + Print)

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.

Major Topics Covered

With a 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.

You’ll...

  • Have not only the laws and regulations at your fingertips – but also analysis of the requirements, and a breakdown of specific 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
  • Gain 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

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About Your Subscription

You will receive the two-volume FDA Advertising and Promotion Manual in print and/or access to the manual online at fda.complianceexpert.com. Based on the delivery method you choose, your annual subscription also includes quarterly print and/or rolling digital updates, news, analysis and more at no additional charge for the 12-month subscription period. Additionally, online subscribers receive access to our FDA Enforcement Letter Database . If you have any questions or would like information about bulk pricing or site licenses, please contact Client Services at 800-677-3789 or by emailing service@thompson.com.


Authors and Editors

Wayne L. Pines

Wayne L. Pines is an internationally-known consultant on regulatory, media and crisis matters involving pharmaceuticals and medical devices. He helps companies address challenges involving the Food and Drug Administration (FDA) or related agencies. He is president of Regulatory Services and Healthcare at APCO Worldwide. Mr. Pines formerly was Associate Commissioner for Public Affairs at the FDA. He is author or editor of several books about advertising and promotion regulation, crisis communications, risk management and FDA regulatory processes. He wrote the FDA Advertising and Promotion Manual, which is published by Thompson Information Services.

Coleen Klasmeier

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.

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