BIO Professional Development
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FDA Digital (Scenarios)
A comprehensive review of the Do's and Don'ts for Digital Tactics: covers drug and medical device advertising, blogging, chat rooms, discussion forums, Facebook and Twitter, links, search (paid and organic) posts, videos, websites, mobile apps, YouTube.
Takeaways
There are many types of digital tactics that can executed to promote a new prescription product
It’s important to understand the regulatory compliance do’s and don’ts for blogging, chat rooms, discussion forums, Facebook and Twitter, links, search (paid and organic) posts, videos, websites, mobile apps, and YouTube
The FDA exercises strict oversight over promotional materials that include mention of a product by name
Enforcement letters illustrate the application of risk communication requirements
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.
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.
A good regulatory strategy is essential to a good business strategy.
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?
