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Advertising and Promotion Considerations for Biologics, Biosimilars, and Interchangeables | Morgan Lewis - As Prescribed

FDA recently issued a revised draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and. ....

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FDA's Office of Prescription Drug Promotion Issues Its First Untitled Letter of the Year to Novartis for Misleading Statement Relating to KISQALI® | Sheppard Mullin Richter & Hampton LLP

On January 18, 2024, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued its first untitled letter of the new year to Novartis. ....

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FDA Issues Letter to Novartis for Misleading Statement

FDA Issues Letter to Novartis for Misleading Statement
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Try, Try Again: FDA Issues Draft Guidance On Communication Of Scientific Information On Unapproved Uses Of Medical Products - Food and Drugs Law

On October 23, 2023, the Food and Drug Administration ("FDA") released a draft guidance for industry entitled "Communications From Firms to Health Care Providers Regarding. ....

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Beyond Reprints for Scientific Information on Unapproved Uses of Medical Products | King & Spalding

Revised Draft FDA Guidance Expands Scope of Permissible Proactive Off-Label Communications This week, FDA published new revised draft guidance, Communications From Firms. ....

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