BIO Professional Development
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FDA Ad Promo (Scenarios)
A comprehensive review of the Do's and Don'ts for AD/Promo Tactics: Covers types of drug and medical device advertising (disease state/unbranded, product/branded, reminder, institutional, recruitment), promotional labeling (booklets, brochures, direct mail, exhibit booths, file cards, monographs, publications, sales aids, videos).
Takeaways
The Ad/Promo Tactics Module described the types of Advertising and Promotional tactics that can be executed to promote a new prescription product
This Ad/Promo Scenarios Module focuses on specific situations that require careful attention to ensure regulatory compliance, specifically: secondary endpoints, drawing comparisons, using a competitor’s published data, Boxed Warning products, open-label data in advertising, fair balance, visual aids, cherry picking, celebrity endorsers, branded and unbranded ads, Mechanism of Action, target audience, risk disclosure, Form 2253, reprints, framing risk information, Quality of Life data, generic brand names In a product claim ad, reference to lifestyle factors in a branded ad and a product appearing on a third-party website
Detailed review of content do's and don'ts including comparative/superiority, charts/graphs, competitor information, “cherry-picking”, disclaimers, references, market research data, quality-of life claims, company spokespeople.
Do we correct information about our drug in a company’s sponsored chat room? What types of websites shouldn’t we link to? Learn the FDA regs and more.
A good regulatory strategy is essential to a good business strategy.
Do we correct information about our drug in a company’s sponsored chat room? What types of websites shouldn’t we link to? Learn the FDA regs and more.
Under what conditions can companies find a safe harbor for communicating investigational data? How and why is scientific exchange codified in the Code of Federal Regulations (CFR). Learn the FDA regs and more.
What are considered good publication practices for communicating company-sponsored medical research and how do these practices impact publication development and planning? Learn more in this pub planning module.
