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Sheppard Mullin Richter & Hampton LLP

Finally, FDA’s Final Word on Unapproved Use Communications

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On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more

Venable LLP

The Major Statement: FDA's Recent Q&A Guidance and Rulemaking on Direct-to-Consumer Prescription Drug Advertisements and the...

Venable LLP on

On December 26, 2023, the Food and Drug Administration (FDA) issued a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear,...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues Final Rule and Guidance on Direct-To-Consumer Prescription Drug Advertisements

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In one of the last guidances released in 2023, the Federal Food and Drug Administration (FDA) finalized guidance for direct-to-consumer (DTC) prescription drug advertisements, specifically advertisements in television and...more

Foley & Lardner LLP

DTC Promotional Labeling and Advertisements: Quantitative Efficacy Wins Over FDA in Final Guidance on Presenting Risk Information

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In June 2023, the U.S. Food and Drug Administration (FDA) published final guidance (Guidance) on presenting risk and efficacy information for direct-to-consumer (DTC) promotional labeling and advertisements for prescription...more

Sheppard Mullin Richter & Hampton LLP

FDA Releases Final Guidance on Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and...

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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) promotional labeling and advertisements for...more

Foley Hoag LLP

OPDP Issues Final Guidance on Best Practices for Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer...

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On June 27, 2023, the Food and Drug Administration’s ("FDA") Office of Prescription Drug Promotion ("OPDP") published a final guidance (the "Final Guidance") on Presenting Quantitative Efficacy and Risk Information in...more

King & Spalding

FDA Finalizes Guidance on Presenting Quantitative Efficacy and Risk Information in DTC Promotion

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On June 28, 2023, the U.S. Food and Drug Administration (“FDA”) issued final guidance on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (“Quantitative...more

Morrison & Foerster LLP

UK’s Financial Services Regulator Issues Draft Guidance on Social Media – should we Favourite* or #Fail?

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On 6 August 2014, the UK’s financial services regulator, the Financial Conduct Authority (FCA), issued long-awaited draft guidance on the use of social media in financial promotions by regulated financial institutions. ...more

Cooley LLP

FDA Holds Teleconference re: Social Media Guidance

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The U.S. Food and Drug Administration (FDA) held a webinar last week to discuss three recently released guidance documents related to regulatory requirements for pharmaceutical and medical device manufacturers, distributors...more

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