SSRI Listening Session Minutes – March 24, 2026
Summary
The FDA's Center for Drug Evaluation and Research (CDER) published minutes from an SSRI listening session held on March 24, 2026, along with three associated attachments. The materials include an overview of a petition (FDA-2025-P-3956) requesting balanced, evidence-based pregnancy warnings for serotonergic reuptake inhibitors, and a presentation on safely deprescribing psychiatric drugs. The session reflects ongoing FDA engagement with stakeholders on the petition but does not constitute a formal agency decision.
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What changed
The document makes available the minutes and presentation materials from an FDA listening session on SSRIs. One attachment summarizes a petition (FDA-2025-P-3956) that calls for the FDA to require balanced, evidence-based pregnancy warnings on serotonergic reuptake inhibitors. A second attachment covers methods for safely discontinuing psychiatric drugs. These materials do not themselves create regulatory obligations but indicate that a live petition is under stakeholder review.
Pharmaceutical manufacturers and healthcare providers with interest in SSRI labeling, pregnancy-related drug information, or psychiatric drug prescribing practices should monitor the related docket (FDA-2025-P-3956) for any subsequent FDA action, including potential request for comment, denial, or grant of the petition. The listening session format signals the FDA is actively gathering input before determining next steps.
Archived snapshot
Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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Attachments 3
SSRI listening session minutes_3-24-26
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- Author(s) CDER
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AbuDagga A. Overview of Petition to Require Balanced Evidence-Based Pregnancy Warnings for SRIs_03.23.2026
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- Author(s) CDER
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Horowitz M. How to safely deprescribe psychiatric drugs_03.23.2026
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- Author(s) CDER
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