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Government, Policy & Advocacy
Government, Policy & Advocacy
Regulation & EnforcementREMS Administrators

Braeburn Inc.

Data updated

Biopharmaceutical company responsible for BRIXADI REMS implementation in the U.S., with certified provider and pharmacy requirements and controlled outpatient distribution pathways.

Regulation & Enforcement Snapshot

REMS Administrators

Authority Type

REMS Program Administrator

Jurisdiction

National

Coverage

1 country

Binding Strength

Programmatic Requirement

Function Areas

Risk Evaluation and Mitigation OversightData Reporting RequirementsCompliance Monitoring and Inspections

Framework / Program

BRIXADI REMS Program

Policy Notes

BRIXADI is distributed under a REMS framework with healthcare setting, prescriber, and pharmacy controls to reduce diversion and unsafe administration pathways.

Verification

Verified

Psychedelic Engagement

Psychedelic-Adjacent Focus

Framework Status

Active

Last Verified

Apr 8, 2026

Primary Policy Link

Source Evidence

FDA BRIXADI REMS Document

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/210136Orig1s000REMS.pdf

FDA BRIXADI Prescribing Information

https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210136s012lbl.pdf

BRIXADI REMS Program

https://www.brixadirems.com/

Quick Facts

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