Gary Messplay

Gary Messplay

King & Spalding

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FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU)

Final Guidance Further Expands Scope of Permissible Proactive Off-Label Communications - On January 6, 2025, FDA finalized its guidance entitled Communications From Firms to Health Care Providers Regarding Scientific...more

1/14/2025  /  Advertising , Compliance , Draft Guidance , Final Rules , First Amendment , Food and Drug Administration (FDA) , Health Care Providers , Marketing , Pharmaceutical Industry , Regulatory Requirements

FDA Defends Its First Amendment Position in “Memorandum”

On January 18, 2017, the Food and Drug Administration (FDA or the Agency) released for public comment a Memorandum, Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding...more

1/26/2017  /  Draft Guidance , First Amendment , Food and Drug Administration (FDA) , Off-Label Promotion , Pharmaceutical Industry , Public Comment
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