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.


  • 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

Course Price:
$200 USD
BIO Member Price:
$160 USD
Course Length:
25 minutes
Course Level:
Course Format:
Suggested Prerequisites

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).

Professional Certificate
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A good regulatory strategy is essential to a good business strategy.

Professional Certificate

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.