Webinars>>Off-Label Promotion Sydney Time
FDA Permitted Off-Label Promotion: The Changing Regulatory Paradigm
FDA has publicly acknowledged that many regulated products have uses beyond what they have been approved for. FDA also recognizes that these unapproved uses may be beneficial to some patients. The so-called off-label uses may be well-known to the physicians and manufacturers. While there are no restrictions on a physician prescribing off-label uses of a product, manufacturers are prohibited for “actively” promoting an off-label use. Recent legal developments have challenged the age-old FDA practice of restricting all discussion of off-label use of a given product by its manufacturer. In light of these, several strategies have evolved to legally discuss off-label uses of FDA-approved products. FDA’s recent rules under which manufacturers can educate physicians and, indirectly, even patients about new uses of their products, have changed the regulatory paradigm. This seminar will discuss the regulatory perspective on promoting off-label uses for manufacturers.
Why should you attend:
Recently the US courts have made some high-profile decisions regarding FDA’s punitive actions to manufacturers accused of off-label promotion. One case, the Caronia case, has been in much discussion since in that case the court sided with the defendant accused of off-label promotion leading to speculation of its impact on FDA’s enforcement of its rules regarding off-label promotion. The legal discussion apart, these cases have raised new regulatory questions about FDA-acceptable practices for promoting off-label uses for approved products. This seminar will discuss the regulatory impact of recent court decisions and strategies for introducing new uses for approved products.
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For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: email@example.com