| FDA Advertising and Promotion Manual |
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Authors: Wayne L. Pines Coleen Klasmeier
Board: Editorial Advisory Board
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, sales and pricing 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, video news releases, 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 totally 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.
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- Two-volume manual
- Updates (12 updates)
- Newsletters
- Online access
- Newsletter archive
- Special Reports
- Email Notifications
- Fully searchable
- Hyperlinking
- Warning Letters Database
- Additional Online Resources
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- Online access
- Newsletter Archive
- Updates (12 updates)
- Special reports
- Email Notifications
- Fully searchable
- Hyperlinking
- Additional Resources
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About This Publication
Thompson’s FDA Advertising and Promotion Manual explains FDA and FTC regulations and guidelines for the advertising and promotion of pharmaceuticals, medical devices, biologics, foods, veterinary medicines and cosmetics. We cover the specifics for each media — the Internet, print ads, scientific symposia, television and radio ads, detailers, video news releases, press releases, sponsored studies, celebrity endorsements, media tours and teleconferences. It’s designed to clarify the legal and regulatory complexities surrounding compliance, and will keep you up to date on new activity at the federal and state level, provide you with expert insight and practical guidance. Everything you need to ensure your compliance policies and procedures and keep your marketing efforts on track and avoid costly marketing mistakes.
With the 12 month subscription to the FDA Advertising and Promotion Manual you’ll receive our two volume manual; monthly updates and newsletter; online access and searchable database; and so much more.
You’ll...
• 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.
• Have access to our subscriber-only Web site that includes our Manual and our searchable database of more than 10,000 FDA Enforcement Letters.
Order today – the right copy – makes all the difference!
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About Your Subscription
You can review this product for 30 days. Your annual subscription includes published updates at no additional charge for the 12 month subscription period. 12 updates are expected. If you cancel your subscription within 30 days of receipt, you will receive a full credit upon return of the product together with a request for cancellation.
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