BIO Professional Development
Through a curated network of education alliance partners, BIO offers industry professionals executive training and development resources for accelerating career growth
FDA Claims
A 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.
Takeaways
Claims are statements that identify or describe the uses of a prescription product
The FDA exercises strict oversight over promotional materials that include mention of a product by name
FDA has specific requirements for making product claims in promotional content
There are do’s and don’ts for making claims using comparative/superiority and quality of life data, market research, competitor information, disclaimers, references, and company spokespeople
Enforcement letters illustrate the application of risk communication requirements
Can you use a competitor’s data in your promotion; or open-label data in your print ad? Learn the FDA regs and more.
Comprehensive review of the Do's and Don'ts for AD/Promo Tactics: covers types of drug and medical device advertising, promotional labeling (booklets, brochures, direct mail, exhibit booths, file cards, monographs, publications, sales aids, videos).
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.
How should reprints with off-label information be issued once they have appeared in peer-reviewed medical journals? Learn the FDA regs and more?
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