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FDA Releases Final Guidance on Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements | Sheppard Mullin Richter & Hampton LLP

On June 27, 2023, the Food and Drug Administration (FDA) issued its final guidance for the presentation of “Quantitative Efficacy and Risk Information” in direct-to-consumer (DTC)...
Sheppard Mullin Richter Hampton Prescription Drug Promotion On Television Study Of Oncology Indications In Television Advertising See Us Food Drug Administration See Untitled Letter To Xeris Pharmaceuticals Publication Office Of Prescription Drug Promotion

I'm Looking Through You/You Won't See Me: FDA Issues Guidance Document Concerning Presentation of Certain Information in DTC Promotional Labeling and Advertising | Arnall Golden Gregory LLP

“I’m Looking Through You” and “You Won’t See Me,” both songs from The Beatles’ 1965 Rubber Soul album, came to mind when we read the Food and Drug Administration’s recently issued...
Drug Administration Looking Through Quantitative Efficacy Risk Information Promotional Labeling Advertisements Guidance

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FDA sheds light on benefit-risk assessments to inform decision-making throughout product lifecycle - Patient experience data can play central role | Hogan Lovells

The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer...
Patient Reported Outcomes Clinical Outcome Assessments Quantitative Efficacy Risk Information Direct To Consumer Promotional Labeling

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