Accelerated approval product sponsors need to take care that promotional materials neither overstate efficacy nor skimp on safety, and the US Food and Drug Administration’s new guidance governing scientific information on unapproved uses potentially creates both opportunities and risks when it comes to communicating about such products, experts said.
Key Takeaways
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Accelerated approval on the basis of a surrogate or intermediate clinical endpoint, in the absence of a confirmed clinical benefit, creates special considerations for advertising and promotion, including requirements to submit promotional materials to the FDA before use.
At the Food and Drug Law Institute’s recent advertising and promotion conference, legal and regulatory experts discussed the unique promotional...
