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(Maybe) I Can See More Clearly Now: FDA Issues Q&A Guidance on DTC Rx Ads | Arnall Golden Gregory LLP

On December 26, 2023, the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a Questions and Answers Guidance for industry titled “Direct-to-Consumer. ....

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Sharing Scientific Information with HCPs on Unapproved Uses of Medical Products: Dos and Don'ts Under FDA's New Draft Guidance | Epstein Becker & Green

In October 2023, the FDA released draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared. ....

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FDA Guidance on Sharing Information with HCPs

FDA Guidance on Sharing Information with HCPs
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Off-Label Communications Back in the Spotlight at the FDA | Wilson Sonsini Goodrich & Rosati

For the first time in almost 10 years, the U.S. Food and Drug Administration (FDA) released a draft guidance related to certain communications by firms to healthcare providers (HCPs) of. ....

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FDA Updates Off-Label Communications Guidance - Life Sciences, Biotechnology & Nanotechnology

On October 23, the U.S. Food and Drug Administration (FDA or Agency) released a much anticipated draft guidance entitled. ....

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