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FDA Issues Overdue Draft Guidance on Clinical Trial Diversity Action Plans

Yesterday, the U.S. Food and Drug Administration (FDA) released its long-awaited draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. This draft guidance replaces the agency’s similarly-titled April 2022 draft guidance and has been issued to satisfy a requirement under the Food and Drug Omnibus Reform Act…

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How to Get Your SIUU Out: FDA Provides Long-Awaited Update for Industry on Communicating Off-Label Information

On October 23, 2023, FDA announced the availability of a revised draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” The draft guidance supersedes the agency’s 2014 draft guidance, “Distributing Scientific and Medical Publications on Unapproved New Uses,” and…

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Are Pre-Approval and Pre-Licensure Inspections Limiting Approvals During COVID-19?

In this post, we discuss FDA’s conduct of inspections of manufacturing facilities for new drugs and biologics during the COVID-19 pandemic. These inspections, known as pre-approval and pre-licensure inspections (PAIs/PLIs, respectively), are performed to give FDA assurance that a manufacturing site named in a new drug or biologics license application…

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