Changeflow GovPing Healthcare & Life Sciences CDER SSRI Listening Session Minutes, March 24, ...
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CDER SSRI Listening Session Minutes, March 24, 2026

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Summary

FDA CDER held a listening session on March 24, 2026 regarding SSRIs (Selective Serotonin Reuptake Inhibitors). The session included a presentation by AbuDagga A. on a petition requesting balanced evidence-based pregnancy warnings for SRIs, and a presentation by Horowitz M. on safe psychiatric drug deprescribing. The main Regulations.gov page displays no downloadable document body despite three listed attachments. This record appears to be an administrative docket entry for the session rather than substantive regulatory action.

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About this source

Every FDA document on regulations.gov, the federal rulemaking portal. This is where the agency posts variances, advisory committee meeting notices, draft guidance for comment, citizen petition responses, and procedural rules that do not get a separate Federal Register slot. Around 240 a month. FDA's heavy regulations.gov use means tracking only the Federal Register misses a meaningful chunk of what the agency does day-to-day. Watch this if you manufacture devices, submit IND or NDA applications, run a lab, or advise sponsors on FDA process. GovPing publishes each posting with the docket, document type, division (CDER, CDRH, CFSAN), and comment window where one applies.

What changed

The document is a Regulations.gov docket entry for FDA CDER's SSRI listening session held March 24, 2026. Three attachments are associated with the docket: the session minutes, a petition overview on pregnancy warnings for SRIs by AbuDagga A., and a presentation on safe psychiatric drug deprescribing by Horowitz M. The main page contains no substantive document body.

Affected parties — including pharmaceutical manufacturers, healthcare providers, and patients — should monitor this docket for potential regulatory developments related to SSRI labeling, pregnancy warnings, and deprescribing protocols. The petition on balanced evidence-based pregnancy warnings may signal future FDA action on SSRI labeling requirements.

Archived snapshot

Apr 24, 2026

GovPing 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.

Content

There are no documents available to view or download

Attachments 3

SSRI listening session minutes_3-24-26

More Information
- Author(s) CDER
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AbuDagga A. Overview of Petition to Require Balanced Evidence-Based Pregnancy Warnings for SRIs_03.23.2026

More Information
- Author(s) CDER
Download

Horowitz M. How to safely deprescribe psychiatric drugs_03.23.2026

More Information
- Author(s) CDER
Download

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Last updated

Classification

Agency
FDA
Published
March 24th, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Docket
FDA-2026-P-1831-0006

Who this affects

Applies to
Pharmaceutical companies Healthcare providers Patients
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug regulatory proceedings Patient safety Pharmaceutical labeling
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Healthcare Public Health

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