BIO Online Learning

Through a curated network of education alliance partners, BIO offers industry professionals executive training and development resources for accelerating career growth

FDA Risk Communication

Effectively communicate risk information, such as the definition and execution of fair balance in promotional materials. Learn common terms such as Brief Summary, Boxed Warning, Important Safety Information, Adverse Event reporting - plus enforcement letters illustrating the application of these requirements.

Takeaways

  • The communication of risk information is critical for promotional compliance 

  • There are specific ways to communicate risk:   Fair Balance, Brief Summary, Boxed Warning, Important Safety Information (ISI) and Adverse event (AE) reporting 

  • Enforcement letters illustrate the application of risk communication requirements 

Course Price:
$145 USD
BIO Member Price:
$115 USD
Course Length:
15 minutes
Course Level:
Introductory
Course Format:
On-Demand
Suggested Prerequisites
FLIP
On-Demand
FLIP

What are the FDA requirements for prescription drug advertising versus promotional labeling? Can secondary endpoints be used in product promotion? Learn the FDA regs and more.

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