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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

Course Price:
$200 USD
BIO Member Price:
$160 USD
Course Length:
25 minutes
Course Level:
Introductory
Course Format:
On-Demand
Suggested Prerequisites
FLIP

Can you use a competitor’s data in your promotion; or open-label data in your print ad? Learn the FDA regs and more.

FLIP

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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