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).
A first-time CEO's playbook to empower you to navigate the commercialization journey effectively.
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.