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Government, Policy & Advocacy
Government, Policy & Advocacy
Public Sector Health & Drug GovernanceNational Ministries & Federal Agencies
Regulation & EnforcementREMS Administrators

U.S. Food and Drug Administration (FDA)

Data updated

US federal regulator for drug development and safety oversight, including psychedelic clinical-investigation pathways.

Public Sector Governance Snapshot

National Ministries & Federal Agencies

Authority Type

Federal Drug / Health Agency

Jurisdiction

National

Coverage

1 country

Framework Status

Active

Function Areas

Policy Framework DevelopmentDrug Scheduling / Controlled Substance GovernanceLicensing / Inspection / ComplianceClinical Guidance Publication

Governance Notes

Wave 1 governance profile seeded for U.S. Food and Drug Administration (FDA).

Verification

Verified

Psychedelic Engagement

Explicit Psychedelic Focus

Last Verified

Apr 13, 2026

Primary Governance Link

Linked Stakeholders

FDA MedWatch

Source Evidence

FDA psychedelic guidance

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/psychedelic-drugs-considerations-clinical-investigations

FDA home

https://www.fda.gov/

Regulation & Enforcement Snapshot

REMS Administrators

Authority Type

Regulatory Agency

Jurisdiction

National

Coverage

1 country

Binding Strength

Statutory / Enforceable

Function Areas

Risk Evaluation and Mitigation OversightCompliance Monitoring and InspectionsSafety Surveillance and Enforcement

Framework / Program

FDA Risk Evaluation and Mitigation Strategies (REMS) Framework

Policy Notes

FDA defines REMS requirements, evaluates compliance via inspections and assessments, and may take enforcement actions for noncompliance.

Verification

Verified

Psychedelic Engagement

Psychedelic-Adjacent Focus

Framework Status

Active

Last Verified

Apr 8, 2026

Primary Policy Link

Source Evidence

FDA - Risk Evaluation and Mitigation Strategies (REMS)

https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems

FDA - REMS Compliance Program

https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/rems-compliance-program

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