Life sciences partner Kellie Combs (Washington, D.C.) is quoted in a Nov. 7 Medical Marketing & Media article about a public hearing held by the U.S. Food and Drug Administration (FDA) regarding issues related to off-label communications.
In the article, Ms. Combs explains that FDA has long acknowledged that providing access to off-label information is critical to the public health, but that FDA regulations and policies governing manufacturers’ off-label speech are unclear and in need of revision. She emphasizes that members of industry have repeatedly asked FDA to clarify its regulatory framework, and that she hopes the public hearing will not further delay agency action on these issues.
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