Nikki Reeves

King & Spalding

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Latest Posts › Off-Label Promotion

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Beyond Reprints for Scientific Information on Unapproved Uses of Medical Products

Revised Draft FDA Guidance Expands Scope of Permissible Proactive Off-Label Communications This week, FDA published new revised draft guidance, Communications From Firms to Health Care Providers Regarding Scientific...more

10/27/2023 / Comment Period , Digital Platforms , Draft Guidance , Food and Drug Administration (FDA) , Medical Supplies , Off-Label Promotion , Off-Label Use

2019 Year in Review: FDA Office of Prescription Drug Promotion

In 2019, the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) issued a total of ten enforcement letters targeting advertising and promotion violations for prescription drugs. Of the ten...more

3/2/2020 / Food and Drug Administration (FDA) , Manufacturers , Off-Label Promotion , OPDP , Pharmaceutical Industry , Prescription Drugs , Warning Letters

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1/26/2017 / Draft Guidance , First Amendment , Food and Drug Administration (FDA) , Off-Label Promotion , Pharmaceutical Industry , Public Comment

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