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Webcast URL: https://www.theknowledgegroup.org/webcasts/fdas-new-off-label-guidance/

Previous Off-label Guidance left unclear boundaries on what exactly is there to abide that only resulted in repeated incidences of violations. Hence, pharmaceutical companies continue to push the U.S. Food and Drug Administration (FDA) as well as the court system to elucidate on the issue.

Recently, the FDA put into print two additional guidance documents, one addressing how insurance companies and other payors can share economic and other information, and the other addressing how companies can communicate information that is not contained in a product's labeling but is still consistent with the labeling. Thus, the latest published documents casts light for pharmaceutical companies and manufacturers in avoiding possible risks and pitfalls when comparing the safety and efficacy of one drug to another.

In this LIVE Webcast, a panel of thought leaders and professionals assembled by The Knowledge Group will provide the audience with an in-depth analysis of the FDA’s New Off-Label Guidance. Speakers will also present the fundamentals and legal considerations of the guidance, as well as tips and strategies to avoid prevalent drawbacks.

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